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34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Mitral Leaflet Prolapse Age > 18 years Degenerative mitral insufficiency with mitral leaflet prolapsed , who are candidates for mitral valve repair according to ESC or ACC/AHA guidelines Patient able and willing to return to the implant center for follow-up visits Able and willing to give informed consent and follow protocol procedures Inadequate echocardiographic window for transthoracic imaging Severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus Evolving endocarditis or active endocarditis in the last 3 months Heavily calcified annulus or leaflets Congenital malformation with limited valvular tissue Patient requires mitral valve replacement Previously implanted annuloplasty ring/band Patient requires aortic or pulmonic valve replacement or repair Patient is pregnant (urine HCG test result positive) or lactating Patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation age ≥ 18 years signed written consent symptomatic patients (NYHA-stadium ≥ III) for at least 3 months with an exploited medical heart insufficiency therapy increased perioperative risk with a logistic EuroScore ≥ 15 or STS-Score ≥ 15 MR grade ≥ 2, amenable for MitraClip intervention assessed by an experienced interventional cardiologist Affirmation of in-operability by a "Heart-Team" consisting of either 1 cardiac surgeon and 1 cardiologist or 3 cardiologists one essential cardiovascular event in the past 6 weeks; i. e. myocardial infarction, stroke, shock, cardiac decompensation, or the necessity of catecholamine therapy for haemodynamic stabilisation implantation of a biventricular pacemaker-device for cardiac resynchronisation therapy in the past 3 months solid tumor with a live expectancy < 1 year | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Prolapse Subject has symptomatic or asymptomatic moderate (2+) or severe (3-4+) mitral regurgitation Subject has an ejection fraction (EF) ≥ 30% Subject is of legal age (≥18 years old) Subject is planned to undergo surgical repair or replacement of the mitral valve for symptomatic or asymptomatic posterior leaflet mitral prolapse Subject requires a complex mitral valve repair or has isolated anterior prolapse Subject has mitral valve stenosis in which the annulus opening is <10mm. Subject has valve disease other than mitral which requires surgical intervention Subject requires a concomitant procedure Subject has a pre-existing prosthetic valve in any position Subject had stenting or PCI within 6 months before the planned procedure, or is anticipated to require stenting or PCI within 6 months post-procedure Subject has calcification of the mitral leaflets or annulus which in the medical opinion of the surgical investigator would limit repair and /or implantation of the investigational device Subject has renal insufficiency or is on chronic dialysis Subject has had a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months Subject has a history of endocarditis or has active endocarditis Subject has a history of autoimmune disease | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Tricuspid Valve Regurgitation, Non-rheumatic Mitral Valve Regurgitation Audible AV valve regurgitation on clinical exam, as noted by most recent clinic note Clinically indicated CMR study scheduled and have had an echocardiogram in the last 6 months Poor quality CMR study Unable to complete a CMR Have a contraindication to CMR scan (e.g., pregnancy, pacemaker or defibrillator presence, unable to hold still within scanner for imaging) Common AV valve Corresponding semilunar valve regurgitation which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR Intracardiac shunts which precludes use of stroke volume comparison as a second means of assessing AVV regurgitation by CMR | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-60.0, Intraarticular Fracture and Post-traumatic Osteoarthritis years of age or older Radiographic evidence of tibial plateau fracture Less than 18 years of age Greater than 60 years of age Any history of pre-existing knee osteoarthritis based on previous diagnosis or suggestive history Any history of autoimmune disease Any history of contralateral intra-articular knee injury | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-85.0, Severe Degenerative Mitral Regurgitation Age 18 years Patients with severe degenerative mitral regurgitation undergoing mitral valve repair at our institution Functional or ischemic mitral regurgitation Presence of relevant (symptomatic) Coronary Artery Disease Inability of exercising on semi supine bicycle | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-75.0, Critical Stenosis of Aortic Valve Male or female Age: 20-75 years Moderate to severe aortic stenosis defined as a continuous wave Doppler determined peak aortic valve jet velocity of 3.0 5 m/s, mean pressure gradient of 25 mmHg, or aortic valve area of 0.76 5 cm2 Asymptomatic aortic stenosis patients, Stationary or minimum dyspnea on exertion (NYHA Fc ≤ I or II) will be included Patients who were prescribed ACEI or ARBs for treatment of hypertension will be enrolled after 2 weeks wash-out period SBP 120-140 mmHg with or without medication regardless of presence of hypertension or not Patients with BP > 140/90 mmHg with or without medication will be included after their BP is controlled with anti-hypertensive medication other than ACEI/ARBs Symptomatic aortic stenosis: presence of exertional dyspnea (≥ NYHA Fc III), angina or syncope Very severe aortic stenosis regardless of presence of symptoms. It was defined as a critical stenosis in the aortic valve area ≤ 0.75 cm2 accompanied by a peak aortic jet velocity ≥4.5 m/s or a mean transaortic pressure gradient ≥50 mm Hg on Doppler echocardiography Uncontrolled HTN (SBP > 160 or DBP >100) without ACEI or ARBs during 2-weeks wash out period in patients who were prescribed ACEI or ARBs for treatment of hypertension Patients with known history of coronary artery disease including myocardial infarction, regardless of the treatment (medication only, percutaneous coronary intervention, or coronary artery bypass grafting) Planned cardiac surgery or planned major non-cardiac surgery within the study period Stroke or resuscitated sudden death in the past 6 months Chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, or nasal corticosteroids is permissible) Untreated hyperthyroidism or hypothyroidism with TSH levels more than 2 times upper limit of normal A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer Female of child-bearing potential who do not use adequate contraception and women who are pregnant or breast-feeding | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-70.0, Morbid Obesity Qualify for gastric bypass or sleeve gastrectomy (fertile females with negative pregnancy test) Willing to comply with scheduled follow up appointments Blood pressure < 140/80 and heart rate < 100 measured three times Treated hypertension with blood pressure still > 140/80 Stroke or myocardial infarction within the last 12 months Angina currently requiring medical treatment On medication or a device to control arrhythmias On a beta blocker to treat hypertension On medications known to interact with ephedrine or caffeine Unable to tolerate side effects Pregnancy Fertile females unwilling to practice effective birth control | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-65.0, Pulmonary Hypertension Mitral Regurgitation patients undergoing mitral valve surgery for chronic mitral regurgitation estimated pulmonary hypertension (systolic PAP > 50 mmHg estimated by the velocity of tricuspid valve regurgitation in preoperative transthoracic echocardiography) patients who agreed to participate in this study and signed written informed consent preoperative supraventricular tachycardia (SVT) atrial fibrillation atrial flutter multiple ventricular ectopic contractions continuous inotropic support LV ejection fraction (EF) < 30% emergent surgery obstructive cardiomyopathy bronchial asthma biochemical evidence of hepatic disease or renal impairment | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Age ≥ 18 years Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient ≥ 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2 Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS Less than moderate aortic regurgitation on preoperative testing Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation Left ventricular ejection fraction ≥ 40% on preoperative testing Physically able and willing to pedal a recumbent bicycle Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement Age < 18 years AS felt by overall clinical impression to be less than severe Aortic valve replacement is urgent or emergent Moderate of more aortic regurgitation on preoperative testing Concomitant mitral or tricuspid valve replacement Left ventricular ejection fraction < 40% on preoperative testing Physically unable or unwilling to pedal a recumbent bicycle Planned aortic valve replacement with a mechanical prosthesis Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria Not willing to undergo randomization to have implanted one of three bioprosthesis | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Pulmonary Hypertension Mitral Valve Disease Age > 18 years Greater than 6 months post-mechanical or bioprosthetic mitral valve replacement or mitral valve repair (quadrangular resection, triangular resection, sliding plasty, and/or annuloplasty) surgery Dyspnea at rest or with exertion (NYHA II, III, or IV) [Symptomatic Study Group] Asymptomatic control group meeting 1 and 2 above Current or prior chronic vasodilator therapy for pulmonary hypertension Known collagen vascular disease HIV infection: Based on self-report /historical diagnosis Portal hypertension Prior anorexigen use History of corrected or uncorrected intracardiac shunt Prior pulmonary embolism Sickle cell disease Left ventricular dysfunction (ejection fraction < 45%) Moderate or severe mitral regurgitation | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Severe Aortic Stenosis Subject must have co-morbidities such that one cardiologist and two cardiac surgeons agree that medical factors preclude operation, based on a conclusion that the probability of death or serious morbidity exceeds the probability of meaningful improvement. Specifically, the predicted operative risk of death or serious, irreversible morbidity is ≥ 50% at 30 days Subjects must meet all of the under at least one of the sub-groups 2a-c: a. Senile degenerative aortic valve stenosis and i. At least one of the following co-morbid conditions: 1. Severe (≥3-4+) mitral valve regurgitation as measured by echocardiography 2. Severe (≥3-4+) tricuspid valve regurgitation as measured by echocardiography 3. End-stage renal disease requiring renal replacement therapy (Stage 5 of the KDOQI CKD Classification) or creatinine clearance <20cc/min but not requiring renal replacement therapy AND ii. mean gradient > 40 mmHg or jet velocity greater than 4.0 m/sec by either resting or dobutamine stress echocardiogram (if the LVEF < 50%), or simultaneous pressure recordings at cardiac catheterization either resting or with dobutamine stress (if the LVEF < 50%) AND iii. an initial aortic valve area of ≤ 0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND/OR b. Low gradient, low output aortic stenosis as defined by the presence of all three of the following i. In the presence of LVEF <50%, absence of contractile reserve, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0m/sec with dobutamine stress echocardiography or simultaneous pressure recordings at cardiac catheterization OR In the presence of LVEF ≥50%, a mean gradient ≥25mmHg and <40mmHg AND jet velocity less than 4.0 m/sec, by echocardiography or simultaneous pressure recordings at cardiac catheterization AND ii. an initial aortic valve area of ≤0.8 cm2 (or aortic valve area index ≤0.5 cm2/m2) by resting echocardiogram or simultaneous pressure recordings at cardiac catheterization AND iii. radiographic evidence of severe aortic valve calcification AND/OR c. Failed bioprosthetic surgical aortic valve Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by New York Heart Association (NYHA) Functional Class II or greater The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the IRB of the respective clinical site The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Clinical Evidence of an acute myocardial infarction ≤30 days before the MCS TAVI procedure Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the MCS TAVI procedure Blood dyscrasias as defined: leukopenia (WBC <1000mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy Untreated clinically significant coronary artery disease requiring revascularization Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support Need for emergency surgery for any reason Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% as measured by resting echocardiogram Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA) Active Gastrointestinal (GI) bleeding that would preclude anticoagulation | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-85.0, Mitral Regurgitation Mitral Insufficiency Eligible patients must meet all the following 1. Signed Informed Consent Form. 2. Male or female aged ≥18 to ≤ 85 years on the day of screening. Females of childbearing potential (not surgically sterilized or more than one year post-menopausal) must have a negative pregnancy test (serum beta-human chorionic gonadotropin (beta-hCG) or urine) within 24 hours prior to mitral valve surgery. 3. Patient must meet one of the following indications for mitral repair surgery according to the European Society of Cardiology (ESC) and the American Heart Association (AHA) guidelines, and must have consented to have such surgery before undergoing the informed consent process for this study Symptomatic patient with chronic severe primary mitral regurgitation (MR), left ventricle ejection fraction (LVEF) > 30% and left ventricle end systolic diameter (LVESD) < 55 mm or Asymptomatic patient with chronic severe primary MR who either Has LV dysfunction (LVEF ≤ 60 % and/or LVESD ≥ 40 mm or Has a preserved LV function (LVEF> 60% and LVESD < 40 mm) together with a likelihood of a successful and durable repair of > 95 % and an expected mortality rate of < 1% or Has a flail leaflet and LVESD ≥ 40 mm together with a high likelihood of durable repair and a low surgical risk or Has a new onset of atrial fibrillation or pulmonary hypertension (systolic pulmonary pressure > 50 mm Hg at rest) or Asymptomatic patient with chronic moderate or severe primary MR who is to undergo cardiac surgery for another indication when the mitral valve (MV) repair can be performed concomitantly Patient with chronic severe or moderate secondary MR and an LVEF > 30 % who is undergoing CABG concomitantly 4. Patient must have a life expectancy of more than 24 months at the time of screening, assuming they undergo mitral valve annuloplasty. 5. Patient must have a mitral valve diameter corresponding to MAR size 26 and leaflet thickness (smallest helix height Eligible patients must not meet any of the following Have had previous cardiac surgery, including but not limited to any of the following: minimally invasive surgery, mitral valve surgery or valvuloplasty, implantation of a prosthetic heart valve or cardiac defibrillator. 2. Have ejection fraction below 30%. 3. Plan to have any concomitant cardiac surgery or procedure other than CABG, tricuspid valve repair, correction of atrial septal defect, closure of auricular appendage, correction of patent foramen ovale and/or ablation therapy for correction of atrial fibrillation performed with the mitral valve repair, which may also leaflet resection and chordae replacement. 4. Have any structural hindrance or heart abnormality that would make use of the MAR technically infeasible, such as a mitral valve of an unusual size or leaflet thickness for which a suitable MAR is not available, or an obstruction or other abnormality that blocks positioning of the MAR. (Final determination to be made during surgery). 5. Show evidence of having had an acute myocardial infarction (MI) within the 30 days preceding the mitral valve repair surgery. 6. Have a history of stroke within the preceding 12 months or have had any stroke that is not completely clinically resolved and/or significant carotid artery disease (subjects with carotid stenosis ≥50% and/or ulceration). 7. Have recent or evolving bacterial endocarditis or be undergoing antibiotic therapy. 8. Have restricted mobility of the mitral apparatus that results in a valvular area less than 3.0 cm2. 9. Be in need of annular decalcification. 10. Have any comorbidities or conditions that would be a contraindication to open heart surgery or that would place the patient at an unacceptable surgical risk, such as: severe chronic obstructive pulmonary disease (COPD); hepatic failure; immunosuppressive abnormalities or other immunological deficiencies including being immunocompromised or having an autoimmune disease; chronic renal failure requiring dialysis; hematological abnormalities including a history of bleeding diathesis or coagulopathy; being unable to follow the locally recommended anticoagulant regimen; an intolerance or hypersensitivity to anesthetics; cancer that requires further radiation, chemotherapy or surgical treatment. 11. Have a contraindication to trans-esophageal echocardiography (TEE)/ Doppler. 12. Have any recent psychiatric disorder, including drug or alcohol abuse, that in the Investigator's opinion could impair the patient's compliance with study procedures. 13. Be currently or have in the preceding 30 days participated in any other study involving an investigational drug or device. 14. Be an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization or have an immediate family member who is | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Repair Surgery patients scheduled to undergo elective mitral valve repair surgery more than moderate mitral stenosis left atrial enlargement signed written informed consent agreements urgent or emergency case other concurrent valvular surgery patient age < 18 years reduced left or right ventricular function (ejection fraction < 40%) mitral regurgitation grade more than moderate repeated surgery for cardiac valvular disease | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Aortic Valve Stenosis Aortic Valve Stenosis With Insufficiency Regurgitation, Aortic Valve Aortic Valve Incompetence Subjects will be required to meet all 1. Male or female, age 18 years or older 2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a planned replace-ment as indicated in the preoperative evaluation 3. Is scheduled to undergo planned aortic valve replacement with or without concomitant coronary bypass surgery 4. Provide written informed consent 5. Geographically stable and agrees to attend follow-up assessments until all subjects have completed 5 years of follow up Subjects will not be eligible for trial participation if any of the following are present: 1. Pure aortic insufficiency 2. Requires emergency surgery 3. Previous aortic valve replacement 4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in situ 5. Requires multiple valve replacement/repair 6. Requires a surgical procedure outside of the cardiac area (e.g., vascular endarterectomy, vascular bypass, tumor removal) 7. Aneurysm of the aortic root and/or ascending aorta requiring surgical intervention 8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months prior to the scheduled AVR surgery 9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement surgery 10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or end-stage renal disease requiring chronic dialysis 11. Hyperparathyroidism 12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic attack (TIA) within 6 months (180 days) of the procedure 13. Presence of non-cardiac disease limiting life expectancy to less than 12 months 14. Hypertrophic obstructive cardiomyopathy (HOCM) 15. Left ventricular ejection fraction ≤ 25% 16. Documented history of substance (drug or alcohol) abuse within the last 5 years 17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 18. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to the procedure 19. Pregnancy, lactation, or planning to become pregnant; 20. Currently incarcerated or unable to give voluntary informed consent 21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding diathesis or coagulopathy 22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's Syndrome) 23. Current or recent participation (within 6 weeks prior to surgery) in an investigational drug or device trial Intra-operative Anatomic variances which contraindicate implant of the trial valve, such as: 1. anomalous coronary arteries 2. annular deformation or extensive calcification of the annulus or aortic root which cannot be removed 3. significant calcium on the anterior mitral leaflet 4. pronounced septal calcification 5. position of coronary ostia relative to Model 8300ACD valve that would result in obstruction of blood flow 25. Available devices are not suitably sized for the subject's annulus | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-80.0, Mitral Regurgitation asymptomatic patients severe degenerative MR preserved left ventricular systolic function According to the recommendations of the 2006 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for surgical indications of severe MR, the for from the study are defined as follows patients with the presence of exertional dyspnea, or angina left ventricular ejection fraction < 0.60 left ventricular end-systolic dimension > 40 mm atrial fibrillation significant aortic valve disease Doppler-estimated systolic pulmonary artery pressure > 50 mmHg patients who were not candidates for early surgery based on age > 80 years and coexisting malignancies patients who did not consent to participate | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Marfan Syndrome Man or woman > 18 years old With a mutation in FBN1 gene Has signed an informed consent form -No affiliated to a Healthcare System | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Heart; Disease, Mitral(Valve) Diseases of Mitral Valve Mitral Valve Insufficiency Asymptomatic Severe organic mitral valve regurgitation Preserved left ventricular function (left ventricular ejection fraction >60% and left ventricular end-systolic dimension ≤45 mm) The likelihood of MV repair should be more than 90% determined by the local heart team with a cardiologist and cardiothoracic surgeon Pulmonary hypertension (>50 mmHg at rest) Atrial fibrillation Physical inability as determined by the heart team to undergo surgery Other life-threatening morbidity Higher expected surgical risks in advance, according to the dedicated heart team Moderate to severe kidney disease (eGFR less than 30 mL/min) Flail leaflet together with a left ventricular end systolic diameter (LVESD) >40 mm | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-80.0, Mitral Valve Prolapse Mitral valve prolapse Other mitral valve diseases | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Aortic Insufficiency Subject is 18 years of age or older Subject has tri-leaflet aortic valve morphology Subject has documented aortic valve disease which may or may not 1. aortic valve insufficiency 2. aortic root pathology 3. pathology of the ascending aorta 4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve Subject has reviewed and signed the written informed consent form Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable) The subject has pre-existing valve prosthesis in the aortic position The subject's aortic valve morphology is not tri-leaflet The subject has active endocarditis Heavily calcified valves The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis Leukopenia Acute anemia (Hb < 9mg%) Platelet count <100,000 cell/mm3 Need for emergency surgery for any reason History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, 3D Transesophageal and Transthoracic Echocardiogram Elective coronary artery bypass grafting surgery, valve repair or replacement surgery, aortic repair or replacement surgery, or any combination of these surgeries years or older for thermodilution assessment are as follows Moderate to severe tricuspid regurgitation Contraindications to pulmonary artery catheter placement based on the American Society of Anesthesiologist's 2003 Practice Guidelines for Pulmonary Artery Catheterization for performance of TEE Contraindications to the performance of TEE based on the Journal of the American Society of Echocardiologists' 2011 recommendations and the American Society of Anesthesiologist Guidelines for Performance of Perioperative Transesophageal Echocardiography Any degree of mitral regurgitation or aortic insufficiency above trace for performance of TTE, both 3D and 2D Qualified echocardiographer absent or unavailable | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation NYHA II-IV Structurally normal mitral valve At least Grade 2 mitral regurgitation Left ventricular ejection fraction not less than 20% and not greater than 45% Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm Pregnant or lactating female Mitral stenosis Mod/severe aortic stenosis or regurgitation Mod/severe tricuspid stenosis or regurgitation Endocarditis Previous mitral valve repair or MV replacement Bioprosthetic or mechanical aortic valve Known unstable angina or MI within 30 days prior to procedure CVA within past 6 months Known contraindications to blood transfusion, contrast dye, DAPT | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 65.0-999.0, Severe Symptomatic Aortic Stenosis Subject has signed the study Informed Consent Form and Data Protection Form prior to participating in the study. 2. Subject is 65 years of age or older at the time of index procedure, and/or has comorbidities that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude surgical valve replacement. 3. Subject's aortic annulus is 19-21mm diameter as measured by echocardiography (echo) or CT conducted within 90 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis with echocardiography derived mean gradient greater than (>) 40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of less than (<) 0.8 cm2 (or aortic valve area index less than or equal to (≤) 0.6 cm2/m2). (Baseline measurement taken by echo within 90 days of index procedure). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II, III, or IV. 6. Subject is deemed high operable risk and suitable for TAVI per the medical opinion of the Subject Selection Committee. 7. Subject's predicted operative mortality or serious, irreversible morbidity risk is less than (<) 50% at 30 days post index procedure Subject is unwilling or unable to comply with all study-required follow-up evaluations. 2. Subject has a documented history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure. 3. Subject has a chest condition than prevents transapical access. 4. Subject has carotid artery disease requiring intervention. 5. Subject has documented evidence of a myocardial infarction (MI) within 6 months (less than or equal to (≤) 180 days) prior to the index procedure. 6. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 7. Subject has mitral valvular regurgitation greater than (>) grade III. 8. Subject has moderate or severe mitral stenosis. 9. Subject has aortic root angulation greater than (>) 70 degrees (horizontal aorta). 10. The distance from the left ventricular apex to the aortic annulus is less than (<) 45mm (4.5cm). 11. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position. 12. Subject refuses any blood product transfusion. 13. Subject refuses surgical valve replacement. 14. Subject has left ventricular ejection fraction (LVEF) less than (<) 20%. 15. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 16. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to (≤) 14 days of index procedure. 17. Subject has severe basal septal hypertrophy that would interfere with transcatheter valve placement. 18. Subject has a history of, or is currently diagnosed with endocarditis. 19. Subject has imaging evidence of intracardiac mass, thrombus, or vegetation. 20. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance). 21. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 22. Subject with significant pulmonary disease as determined and documented by the Investigator. 23. Subject has significant chronic steroid use as determined and documented by the Investigator. 24. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 25. Subject has renal insufficiency as evidenced by a serum creatinine greater than (>) 3.0 mg/dL (265.5µmol/L) or end-stage renal disease requiring chronic dialysis. 26. Subject has morbid obesity defined as a BMI greater than or equal to (≥) 40. 27. Subject has ongoing infection or sepsis. 28. Subject has blood dyscrasias (e.g., leukopenia, acute anemia, thrombocytopenia, history of bleeding diathesis, or coagulopathy). 29. Subject has a current autoimmune disease that, in the opinion of the Principal Investigator or the Subject Selection Committee, precludes the subject from study participation. 30. Significant ascending aortic disease documented by diameter greater than 40mm. 31. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 32. Subject is currently participating in another investigational drug or device study. 33. Subject requires emergency surgery for any reason. 34. Subject has a life expectancy less than (<) 12 months. 35. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator or the Subject Selection Committee, preclude the subject from study participation. 36. Subject is diagnosed with dementia or admitted to a chronic care facility which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 37. Subject has a documented allergy to contrast media, nitinol alloys, porcine tissue, or bovine tissue | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-90.0, Turner Syndrome Bicuspid Aortic Valve Marfan Syndrome Turner syndrome (TS). A TS verified by genotyping Age > 18 years Awaiting operation due to aortic dilation B Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery) Marfan syndrome (MS) A Females with MS verified clinically or by genotyping Age > 18 years Awaiting operation due to aortic dilation B Previous aortic dissection or operation of the aorta (per-cutaneous or open surgery) Bicuspid aortic valve A Females with Bicuspid aortic valve | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-79.0, Mitral Valve Regurgitation Age >= 18 and < 80 years Candidate for surgical mitral valve repair or replacement Isolated posterior leaflet prolapse Moderate to severe or severe mitral valve regurgitation that is degenerative in nature Anterior or bi-leaflet prolapse Functional or ischemic MR NYHA Class IV Complex mechanism of MR (leaflet perforation, etc) Significant tethering of leaflets toward LV apex Severely calcified mitral valve annulus Inflammatory valve disease Severe LV dilation | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases Grade 3+ or 4+ mitral valve regurgitation Heavily calcified valves Valvular retraction with severely reduced mobility Active bacterial endocarditis Complex mechanism of MR (leaflet perforation, etc.) Significant tethering of leaflets Inflammatory valve disease | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve Repair Patients with Mitral valve prolapse who undergo mitral valve repair using neochorda Nothing | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-999.0, Mitral Valve Insufficiency Age > 18 or 21 years (Legal age according to the countries involved in this study) Presence of at least moderate chronic OMR defined as an ERO ≥20mm2 and/or a regurgitant volume ≥30mL MR due to ischemic heart disease or cardiomyopathy > mild mitral stenosis, aortic regurgitation, aortic stenosis or pulmonary stenosis previous valve operation history of myocardial infarction or angiographycally documented coronary stenosis congenital or pericardial heart disease endocarditis contra-indication or inability to exercise pregnancy Class I or II indication for mitral valve operation according to the 2006-2007 ACC/AHA/ESC guidelines Typical contraindications to contrast-enhanced MRI (surgery in the last 3 months, defibrillator, pericardial electrodes, brain surgery, aneurysm clipping, neurostimulator, electric stimulation device or magnetically activated, cochlear implant, insulin pump or medication delivery device, Swan-Ganz catheter) | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Age > 18 years Moderate to severe functional Mitral Regurgitation (MR) Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including Cardiac Resynchronization (CRT) if indicated Left Ventricle Ejection Fraction (LVEF) ≥ 25%, LVEDD ≤ 65mm Subject is high risk to undergo Mitral Valve (MV) surgery (as assessed by a surgeon and a cardiologist, at the site) Transseptal catheterization and femoral vein access is determined to be feasible Subject is able and willing to give informed consent and follow protocol procedures Active bacterial endocarditis Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue Heavily calcified annulus or leaflets Subjects in whom transesophageal echocardiography is contraindicated Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization CRT implant within 3 months prior to procedure Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) within 6 months or severe carotid stenosis (>70% by Ultra sound) Renal insufficiency requiring dialysis Life expectancy of less than twelve months | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-50.0, Gestational Diabetes Obesity Pregnant years and older Body mass index >=30.0 <20 weeks gestation at presentation for care Prior cesarean History of bariatric surgery Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement) Chronic prednisone use Known fetal anomalies Multifetal gestation | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Aortic Stenosis Severe aortic stenosis, defined as aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2) by the continuity equation, AND mean gradient > 40 mmHg or maximal aortic valve velocity > 4.0 m/sec by resting echocardiogram. 2. Estimated 30 day mortality risk of > 15% by study center Heart Team assessment,33 OR at least two cardiovascular surgeons from the study center deny surgery because of prohibitive operative risk, estimated to be a combined >50% risk of irreversible mortality or morbidity. 3. Symptoms of aortic stenosis, and NYHA Functional Class II or greater. 4. The subject meets the legal minimum age to provide informed consent based on local regulatory requirements, and has provided written informed consent as approved by the EC/IRB of the respective clinical site. 5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Clinical Subject has been offered SAVR but has declined. 7. Any condition considered a contraindication for placement of a bioprosthetic valve (e.g. subject is indicated for mechanical prosthetic valve). 8. Known hypersensitivity or contraindication to Nitinol. 9. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 10. Untreated clinically significant coronary artery disease requiring revascularization. 11. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) <20% by echocardiography, contrast ventriculography, or radionuclide ventriculography. 12. End stage renal disease requiring chronic dialysis of creatinine clearance < 20 cc/min. 13. Ongoing sepsis, including active endocarditis. 14. Any condition considered a contraindication to extracorporeal assistance. 15. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent performed within 30 days prior to Heart Team assessment, or within six months prior to Heart Team assessment for procedures with a drug eluting stents. 16. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within eight weeks of Heart Team Assessment . 17. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 18. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 19. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 20. Subject refuses a blood transfusion. 21. Severe dementia (resulting in either inability to provide informed consent for the study/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). 22. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions. 23. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-ups exams. 24. Currently participating in an investigational drug or another device study (excluding registries). 25. Evidence of an acute myocardial infarction ≤30 days before the index procedure. 26. Need for emergency surgery for any reason. 27. Liver failure (Child-C). 28. Subject is pregnant or breast feeding. Anatomical Pre-existing prosthetic heart valve in any position. 30. Mixed aortic valve disease (aortic stenosis with moderate or severe aortic regurgitation). 31. Severe mitral regurgitation. 32. Severe tricuspid regurgitation. 33. Moderate or severe mitral stenosis. 34. Hypertrophic obstructive cardiomyopathy. 35. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass thrombus or vegetation. 36. Congenital bicuspid or unicuspid valve verified by echocardiography | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Healthy Healthy males and females, non-vegetarians, non-smokers, age 18-65 with BMI 18-35 kg m-2, taking no medication Diabetes Severe gastrointestinal disorders Kidney disease Thromboembolic or coagulation disease Hepatic disease Alcohol or any other substance abuse Gout Eating disorders Allergy Unregulated thyroid disease Asthma Eczema Hay fever Gluten/wheat intolerance Psychiatric disorder resulting in a perceived inability to give informed consent (including severe depression, lithium treatment, schizophrenia, severe behavioral disorders) Medication (Confirmed with GP) Orlistat (Xenical) Oral antidiabetics, insulin Digoxin, anti-arrhythmics Anti-inflammatories/anti-pyretics Tricyclic antidepressants, neuroleptics Antihistamines | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Functional Mitral Regurgitation Age >18 years Subjects with clinically significant mitral regurgitation (MR 2+ and above) Ejection Fraction ≥ 25% Stable cardiac medical regimen for heart failure for at least 1 month Stable NYHA Classification for at least 1 month Subject is eligible for cardiac surgery The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent Myocardial infarction within 90 days of the intended treatment with the device Prior surgical, transcatheter, or percutaneous mitral valve intervention Any intervention for coronary artery disease (CAD) within the last 30 days prior to treatment, or unrevascularized multivessel coronary disease Hemodynamic instability or the need for emergent surgery Non-ambulatory NYHA Class IV symptoms of heart failure or subjects requiring IV inotropic support Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained Echocardiography evidence of primary mitral valve disease causing MR or MS Evidence of mitral valve stenosis with an estimated valve area less than 3.0 cm2 Mitral valve prosthesis or pathology that would prevent adequate function of the GDS Accucinch System Estimated GFR of <30ml/min/1.73m2 | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Cardiovascular Diseases Age > 18 years old Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm² New York heart Association Class≥ II Left ventricular ejection fraction between 15% and 40% Minimum of 1 hospitalization for heart failure within 12 months preceding randomization Optimal standard of care therapy for heart failure according to investigator Not eligible for a mitral surgery intervention according to the Heart Team Willingness to participate in the study and signed written informed consent Affiliation to a health insurance system or a similar system Eligible for a mitral surgery intervention according to the Heart Team Primary mitral regurgitation Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization Cardiac resynchronization therapy within three months prior to randomization Cardioversion within three months prior to randomization Transcatheter aortic valve implantation within three months prior to randomization Need for any cardiovascular surgery (including registration on cardiac transplant list) Coronary angioplasty within one month prior to randomization Previous surgical mitral valve repair Renal replacement therapy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Patients screened in II Study will first be screened for high risk (HR) status and enrolled into the HR arm if they meet for this arm of the study. If they do not meet for the HR arm, patients will be further screened for for enrollment into the non-high risk (NHR) arm. Key The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve (MV) Male or non-pregnant female Trans-septal catheterization is determined to be feasible by the treating physician High Risk Arm Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥12% or, in the judgment of a cardiac surgeon, the patient is considered a HR surgical candidate due to the presence of one of the following indications: 1. Porcelain aorta or mobile ascending aortic atheroma 2. Post-radiation mediastinum 3. Previous mediastinitis 4. Functional MR with EF <40 5. Over 75 years old with EF<40 6. Re-operation with patent grafts 7. Two or more prior chest surgeries 8. Hepatic cirrhosis 9. Three or more of the following STS high risk factors 9.1 Creatinine >2.5 mg/dL 9.2 Prior chest surgery 9.3 Age over 75 9.4 EF<35 Symptomatic moderate to severe (3+) or severe (4+) chronic MR and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower Non-High Risk Arm Moderate to severe (3+) or severe (4+) chronic MV regurgitation and: 1. Symptomatic with >25% LVEF and LVESD ≤55mm or, 2. Asymptomatic with one or more of the following: i. Left Ventricular Ejection Fraction (LVEF) 25% to 60% ii. Left Ventricular End-Systolic Diameter (LVESD) ≥40 mm iii. New onset of Atrial fibrillation (AFib) iv. Pulmonary arterial systolic pressure (PASP) >50 mmHg at rest or >60 mmHg with exercise Candidate for MV repair or replacement surgery, including cardiopulmonary bypass Key Evidence of an Acute Myocardial Infarction (AMI) in the prior 12 weeks of the intended treatment In the judgment of the Investigator, the femoral vein cannot accommodate a 24 French scale (F) catheter or the presence of an inferior vena cava (IVC) filter would interfere with advancement of the catheter or ipsilateral Deep Venous Thrombus (DVT) is present MV orifice area <4.0 cm2 If leaflet flail is present: 1. Flail Width ≥15 mm, or 2. Flail Gap ≥10 mm If leaflet tethering is present: 1. Vertical coaptation length <2 mm Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may 1. Evidence of calcification in the grasping area of the A2 and/or P2 scallops 2. Presence of a significant cleft of A2 or P2 scallops 3. More than one anatomic dimensionally near the limits 4. Bileaflet flail or severe bileaflet prolapse 5. Lack of both primary and secondary chordal support Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction or cardiogenic shock or the need for inotropic support or intra-aortic balloon pump) Need for emergency surgery for any reason Prior MV surgery or valvuloplasty or any currently implanted mechanical prosthetic valve or currently implanted Ventricular assist device (VAD) Echocardiographic evidence of intracardiac mass, thrombus or vegetation | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-45.0, Vitamin D3 Deficiency Any mother (18-45 years of age) who presents to her obstetrician or midwife at the Medical University of SC (MUSC), Charleston, SC obstetrical facilities within the first 14 weeks after her last menstrual period (LMP) with confirmation of a singleton pregnancy will be eligible for enrollment in the study. Mothers of diverse ethnic backgrounds (African-American, Asian, Caucasian and Hispanic) will be actively recruited Mothers with pre-existing calcium, uncontrolled thyroid disease, parathyroid conditions, or who require chronic diuretic or cardiac medication therapy including calcium channel blockers will not be eligible for enrollment into the study. Mothers with pre-existing sickle cell disease (not trait only), sarcoidosis, Crohn's disease, or ulcerative colitis may not participate in the study. In addition, because of the potentially confounding effect of multiple fetuses, mothers with multiple gestations will not be eligible for participation in the study. A sub-group of approximately 100 subjects with known diabetes, hypertension, HIV, or morbid obesity (body mass index > 49) will participate in the study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Mitral Valve Regurgitation Mitral Valve Incompetence Mitral Regurgitation Mitral Insufficiency Candidates for the high risk arm of the study must meet all of the following Predicted procedural mortality risk calculated using the STS surgical risk calculator of ≥ 12% or in the judgment of the surgeon investigator the patient is considered a high risk surgical candidate due to the presence of one of the following indications: 1. Porcelain aorta or mobile ascending aortic atheroma 2. Post-radiation mediastinum 3. Previous mediastinitis 4. Functional MR with EF<40 5. Over 75 years old with EF<40 6. Re-operation with patent grafts 7. Two or more prior chest surgeries 8. Hepatic cirrhosis i Three or more of the following STS high risk factors: i) Creatinine > 2.5 mg/dL ii) Prior chest surgery iii) Age over 75 iv) EF<35 Age 18 years or older Symptomatic moderate to severe (3+) or severe (4+) chronic mitral regurgitation (MR) and in the judgment of the investigator intervention to reduce MR is likely to provide symptomatic relief for the patient. MR is determined as defined in Appendix A of the II study protocol. American Society of Anesthesiologists (ASA) physical status classification of ASA IV or lower The primary regurgitant jet originates from malcoaptation of the A2 and P2 scallops of the mitral valve Male or Female. Female subjects of childbearing potential must have a negative pregnancy test within seven (7) days before the procedure The subject or the subject's legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board of the respective clinical site The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Transseptal catheterization is determined to be feasible by the treating physician Candidates will be excluded from the study if any of the following conditions are present Evidence of an acute myocardial infarction in the prior 2 weeks of the intended treatment (defined as: Q wave or non-Q wave infarction having creatine kinase (CK) enzymes ≥ two times (2X) the upper laboratory normal limit with the presence of a Creatine Kinase MB Isoenzyme (CKMB) elevated above the institution's upper limit of normal) In the judgment of the Investigator, the femoral vein cannot accommodate a 24 F catheter or presence of ipsilateral deep vein thrombosis (DVT) Ejection fraction < 20%, and/or end-systolic dimension > 60 mm as defined in Appendix A of the II protocol Mitral valve orifice area < 4.0 cm2 as defined in Appendix A of the II protocol If leaflet flail is present: 1. Flail Width: the width of the flail segment is greater than or equal to 15 mm, as defined in Section 4.3 and Appendix A, or 2. Flail Gap: the flail gap is greater than or equal to 10 mm, as defined in Section 4.3 and Appendix A If leaflet tethering is present: a). Coaptation Length: the vertical coaptation length is less than 2 mm, as defined in Section 4.3 and Appendix A Leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in MR. This may Evidence of calcification in the grasping area of the A2 and/or P2 scallops Presence of a significant cleft of A2 or P2 scallops | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Insufficiencies Myocardial Protection The study protocol was approved by the local ethical committees. Eligible for operation were: Inclution patients with mitral regurgitation equal to or larger than grade 3 out of 4 Ablation for atrial fibrillation was the only concomitant procedure that was allowed in addition to mitral valve surgery and these patients were block-randomized to ensure equally many patients with ablation in the two groups of cardioplegia Patients with any other concomitant heart valve disease or coronary artery stenoses (≥ 50%) were excluded from the study Age below 18 Pregnant | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 13.0-999.0, Marfan Syndrome Male or female, aged 13 years or above at last birthday (note that there is no upper age limit for in this trial) For those aged greater than or equal to 16 years of age at the time of enrolment, participant is willing and, in the opinion of the investigator, able to give informed consent for participation in the trial For those aged 13-15 at the time of enrolment, participant is willing and, in the opinion of the investigator, able to give informed assent, and parent/guardian is willing and able to give informed consent for participation in the trial Weight ≥ 50kg Diagnosed with Marfan syndrome according to the revised Ghent 1996 Dilated aorta (BSA-adjusted aortic root z-score ≥2 at the aortic sinuses of Valsalva, using the method of Roman et al, or an absolute aortic root dimension >4.0cm at the sinuses of Valsalva measured using either echocardiography or CMR) If the participant is a female of child-bearing potential, they are willing to ensure effective contraception as defined in the contraception policy If the participant is taking β-blocker therapy, they are willing to stop taking these one week prior to each CMR scan Willing and, in the investigator's opinion, able to comply with all trial requirements Willing to allow his or her General Practitioner and if appropriate, Consultant, to be informed of his or her participation in the trial and of any clinical findings or issues which may arise Female who is pregnant Female who is planning pregnancy within 6 months of enrolment Female who is breast feeding Previous aortic dissection Previous aortic surgery Bicuspid or unicuspid aortic valve Scheduled elective cardiac or aortic surgery within 6 months of enrolment Definite diagnosis of Loeys-Dietz or Shpritzen-Goldberg syndrome Known bilateral renal artery stenosis or renal artery stenosis to a single functioning kidney History of idiopathic intracranial hypertension | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 30.0-80.0, Mitral Valve Stenosis With Incompetence or Regurgitation diagnosis of mitral valve insufficiency with or without coronary artery disease and a LVEF of ≤ 45 % unstable angina diabetes mellitus treated with insulin, clinical findings of acute or chronic renal failure (sCr > 1.5 mg dL-1) severe hepatic disease (alanine aminotransferase or aspartate aminotransferase > 100 U litre L-1) severe chronic obstructive pulmonary disease (forced expired volume in 1 s < 50 % of predicted or < 2.0 litre) a history of prior CABG surgery or myocardial infarction (MI) within the previous month emergent operations patients on inotropic support before operation aortic valvular disease, and infective endocarditis | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Disease All patients requiring the use of an mitral anuloplasty device to restore the mitral competence by surgery are potential candidates for study if survival of at least more than 1 year is expected | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Local Anaesthesia Percutaneous Repair severe mitral regurgitation PMVR using the MitraClip® system | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-50.0, Complication of Surgical Procedure Infant * prior surgical treatment for gut chest surgery (non cardiac) or non-surgical infants who will require a minimum of 2 weeks of non-oral formula/breast milk feedings may be receiving oxygen therapy and intravenous therapy may have previously been treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted ventilation. Maternal *must be able to read and comprehend English. Infant *infant receiving assisted ventilation | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation severe mitral regurgitation percutaneous mitral valve repair (PMVR) with the MitraClip® system < 18 years Patients considered by the heart team to be unlikely to receive meaningful or durable clinical benefit from the procedure | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Atrial Fibrillation Able to sign Informed Consent and Release of Medical Information forms Age ≥ 18 years Clinical indications for mitral valve surgery for organic mitral valve disease Note: May need for surgical management of functional tricuspid regurgitation or patent foramen ovale. Surgical intervention may be performed via sternotomy or minimally invasive procedure a) Persistent atrial fibrillation (AF) within 6 months prior to randomization, defined as non self-terminating AF lasting greater than 7 days but no more than one year, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion. Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment within 6 months prior to randomization. b) Longstanding persistent AF is defined as continuous AF of greater than one year duration. Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the OR left atrial diameter > 65mm Able to use heart rhythm monitor AF is paroxysmal AF without indication for mitral valve surgery Concomitant coronary artery bypass grafting (CABG), aortic arch or aortic valve procedure Previous catheter ablation for AF Redo cardiac surgery Left ventricle ejection fraction (LV EF) < 35% Life expectancy of less than one year Mental impairment or other conditions that may not allow subject to understand the nature, significance, and scope of study | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Hypertrophic Obstructive Cardiomyopathy Able to sign Informed Consent and Release of Medical Information forms Age ≥ 18 years obstructive hypertrophic cardiomyopathy surgically significant mitral insufficiency II-IV (NYHA) average systolic pressure gradient greater than 50 mm Hg. Art. at rest basal or medium ventricular obstruction Related defect of the aortic valve Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis) Surgically significant coronary artery lesions Patients requiring implantation of a cardioverter-defibrillator | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-60.0, Right Ventricular Outflow Tract Stenosis RVOT stenosis who have undergone transannular patch repair with moderate to severe pulmonary regurgitation Isotopic or CMR of and ≤160mL/m2 Age≥18 years and ≤60 years (Zhongshan Hospital age≥18 years and ≤60 years Body weight≥18 kg Pulmonary annular diameter between 14mm to 31mm RVOT length≥20mm The subject or his/her legal representative has provided written informed consent Subject will comply with protocol required follow-ups Add any of the following conditions Subject is symptomatic Subject presents with >30% pulmonary regurgitation fraction as defined by cardiac MRI Candidates will be excluded from the study if any of the following conditions are present Existing pulmonary artery branch stenosis or artificial pulmonary valve Severe chest wall deformity ADHF Active infection or endocarditis requiring antibiotic therapy Leukopenia (WBC<3000mm3) Acute or chronic anemia (Hb<9g/L) Platelet account <100,000 cells/mm3 In the judgment of the investigator, percutaneous introduction and delivery of the valve is not feasible A known hypersensitivity to aspirin or heparin | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Hip Osteoarthritis Leg Length Discrepancy Dislocation Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital Pre-operative flexion contracture >30°, infection, or inability to achieve rigid fixation of instruments intra-operatively | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-5.0, Mitral Valve Disease Damaged Mitral Valve Malfunctioning Mitral Heart Valve Mitral Valve Replacement IDE Cohort - 1. Subject requires mitral valve replacement.* 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study other than those noted in the 1. Subject is > 5 years of age. 2. Subject has a contraindication to anticoagulant/antiplatelet medication. 3. Subject has a prosthetic valve(s) at a site other than the mitral valve prior to the study procedure.* 4. Subject requires concomitant replacement of the tricuspid, pulmonary, or aortic valve. 5. Subject has active endocarditis. 6. Subject has active myocarditis. 7. Subject has had an acute preoperative neurological deficit that has not returned to baseline or stabilized ≥ 30 days prior to the study procedure. 8. Subject has had an acute cardiac adverse event that has not returned to baseline or stabilized ≥48 hours prior to the study procedure. 9. Subject has a non-cardiac illness resulting in a life expectancy of < 1 year. 10. Subject has a known requirement for additional cardiac surgery within 12 months after the study procedure. 11. Subject has been previously enrolled and implanted in this study. 12. Subject is participating in another study for an investigational drug and/or device. 13. Subject has any other medical condition that in the opinion of the Investigator will interfere with the study results Subjects who have undergone a previous Ross procedure of the pulmonary valve are eligible for this study. Continued Access Cohort- Prospective 1. Subject requires mitral valve replacement.* 2. Subject's legally authorized representative gives written consent to participate in the clinical study. 3. Subject is willing and able to return for data collection and follow-up for the duration of the clinical study Subjects undergoing concomitant procedures (e.g. valve repair) are eligible for this study. Prospective Subject is > 5 years of age. 2. Subject has a contraindication to anticoagulant/antiplatelet medication. Retrospective 1. The subject must have been ≤ 5 years of age at the time of mitral valve replacement with the 15mm MHV. 2. An implant was attempted with the 15mm MHV, where implant attempt is defined as the device physically contacting the subject's cardiac anatomy. 3. The legally authorized representative signs the study informed consent for this protocol allowing access to all relevant historical medical information and prospective follow-up (if applicable). 4. Either 1. the legally authorized representative and site agree to follow the subject per the assessment schedule and complete all required assessments per this protocol from the time of consent going forward. OR 2. the subject's status is deceased or explanted, but an implant with 15mm MHV was attempted | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 21.0-80.0, Osteoarthritis Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty Between the ages of 21 and 80 inclusive Patients willing and able to comply with follow-up requirements and self-evaluations Ability to give informed consent Active or prior infection Medical condition precluding major surgery | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Thoracic Aorta Dilatation Marfan Syndrome Thoracic aorta dilatation Marfan syndrome phenotype as in the Ghent II criteria None of the inclusions criteria | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-50.0, Diabetes Mellitus Metabolic Syndrome Postpartum women with diagnosis of gestational diabetes mellitus Want to use implant contraception or nonhormonal contraceptions such as IUD or tubal sterilization Age less than 18 years old Diagnosis of diabetes mellitus at post partum period Cardiovascular disease, Liver disease, autoimmune disease The women that reject to continue in the study | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Obesity Aged between 18 and 65 years old Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) Patient who has benefited from an upper GI endoscopy with biopsies Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass Patient who understands and accepts the need for a long term follow-up Patient who agrees to be included in the study and who signs the informed consent form Patient affiliated to a healthcare insurance plan History of esophagitis on upper GI endoscopy (Los Angeles classification) Severe gastroesophageal reflux disease (GERD), resistant to medical treatment Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy Presence of Helicobacter Pylori resistant to medical treatment Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty) Presence of a severe and evolutive life threatening pathology, unrelated to obesity Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks) Pregnancy or desire to be pregnant during the study Binge eating disorders or other eating disorders according to DSM V | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Nasal Valve Collapse Eligible participants are: 1. Adult patients seeking treatment for nasal obstruction on one or both sides of the nose who are willing to undergo an office-based or intraoperative nasal implant procedure in lieu of alternative treatments (ie, surgical repair or use of an external dilator). 2. Nasal valve collapse (NVC) must be a primary or significant contributor to the subject's nasal obstruction based on clinical presentation, physical examination and nasal endoscopy. 3. Baseline Nasal Obstruction Symptom Evaluation (NOSE) score must be ≥55. Participants are excluded for the following: 1. Surgical or non-surgical treatment of the nasal valve or rhinoplasty within 12 months before enrollment. 2. Septoplasty, inferior turbinate reduction, or other surgical nasal procedures within 6 months before enrollment. 3. Recurrent nasal infections. 4. Use of intranasal steroids within 2 weeks preimplant and 2 weeks post implantation. 5. Presence of a permanent implant, dilator, or uses an external device in the nasal area. 6. Cancerous or precancerous lesions and/or radiation exposure in the treatment area or chemotherapy within 24 months of the study. 7. Significant bleeding disorders. 8. Significant systemic diseases. 9. Currently using nasal oxygen or continuous positive airway pressure (CPAP) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-60.0, Marfan Syndrome Loeys-Dietz Syndrome Thoracic Aortic Aneurysm and Dissection Syndromes Ehlers-Danlos Type IV Syndrome Turner Syndrome To be in the study, the participant must meet the following 1. Diagnosis of hereditary aortopathy based upon Confirmation of a disease causing mutation in a known aortopathy disorder OR Confirmation of disease based on published clinical 2. Participants is male or female and greater than 30 days old 3. Participants are able to undergo standard of care cardiac monitoring including an echocardiogram 4. Willing and able to provide written informed consent by parent(s) or guardian(s) after the nature of the study has been explained and prior to any research related procedures 5. Signed HIPPA compliant research authorization Participant will be excluded from the study for any of the following 1. Diagnosis of a hereditary aortopathy can not be confirmed 2. Existence of an additional comorbid condition including a co-existing genetic syndrome, heart failure, renal disease, rheumatologic disease, history of malignancy, thyroid disease, recent stroke, other life-limiting illness not related to cardiovascular disease. 3. Extreme prematurity, <28 weeks gestational age | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Pre-Eclampsia Severe PE was defined as at least one of the following systolic pressure ≥160 mmHg or diastolic pressure ≥110 mmHg, severe proteinuria (>5 g/24 h), oliguria (<500 ml/24 h), cerebral or visual disturbances, pulmonary edema, epigastric pain, hepatic rupture, impaired liver function, thrombocytopenia, hemolysis, elevated liver enzymes and low platelet count (HELLP) syndrome and evidence of fetal compromise previous serum creatinine levels >1 mg/dl previous kidney disease contraindication to spinal anesthesia | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 60.0-999.0, Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG) Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation Patients Waiting for Mitral Valve Repair/Replacement for Moderate Stenosis or Severe Regurgitation Patients Waiting for Combined Procedures. (CAGB and Valve) Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and < 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery Patients with an estimated ≥ 6 week wait time Patients who have unstable or recent unstable cardiac syndrome as defined by: 1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms 2. Critical left main (LM) coronary disease 3. Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization Patients who have severe left ventricular obstructive disease as defined by: 1. Severe aortic or mitral stenosis (aortic or mitral valve area <1.0cm2 or mean gradient > 40 mmHg or > 10 mmHg respectively) 2. Dynamic left ventricular (LV) outflow obstruction Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias Patients who have cognitive deficits that would preclude rehabilitation Patients who have physical limitations that would preclude rehabilitation Patients who are unable to attend the Prehab program | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation Severe symptomatic mitral regurgitation (Stage D) High surgical risk for open mitral valve surgery Subject meets the anatomical for available size(s) NYHA Class III or IV heart failure DMR deemed by the heart team to be operable Prohibitive risk, deemed too frail or listed for cardiac transplant Unsuitable cardiac structure | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Morbid Obesity Subject is willing to give consent and comply with evaluation and treatment schedule 2. 18 to 65 years of age 3. Have a BMI > 30 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. these conditions but are not limited to Hyperlipidemia Type 2 diabetes Mild Obstructive Sleep Apnea Hypertension Osteoarthritis of the hip or knee 4. Agree to refrain from any type of weight-loss drug ( prescription or OTC) or elective procedure that would affect body weight for the duration of the trial 5. HbA1C < 11 % 6. For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more complex than oral metformin plus one oral sulfonylurea plus once daily insulin injection. 7. Ability to self-pay for the procedure and follow up | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Macular Disease Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS Patients who are agreed with the participation of this study None | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation Severe mitral regurgitation of primary or secondary etiology 2. NYHA functional Class ≥ II. If IV, patient must be ambulatory 3. Heart team determines patient is not a suitable candidate for traditional surgical treatment 4. Age 18 years or older Severe mitral calcification or mitral stenosis 2. Chest condition that prevents transapical access 3. Prior surgical or interventional treatment of mitral or aortic valves | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Cataract Extraction The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye The intended operative eye has a Snellen best corrected visual of 20/40 or worse for distance or the refraction worsens to this level with glare testing The patients' worse seeing Eye is 20/70 or better The patient is willing and able to complete all required postoperative visits The patient is willing to sign a statement of informed consent The patient is at least 21 years old The patient requires cataract surgery with IOL implantation The patient has observed or suspected weakened, torn, missing or otherwise compromised zonules (torn or missing estimated not to exceed one-third of the capsular bag diameter) due to Pseudoexfoliation Syndrome, Marfans Syndrome, trauma or other zonular compromising condition The capsule is intact during insertion Only one functional eye Capsular bag tearing beyond the point where the surgeon thinks it is in the best interest of the patient to have a capsular ring implanted Significant zonular didlysis during surgery Preoperative ocular infection Ocular inflammation or uveitis Amblyopia Aniridia Congenital cataracts Cataracts due to rubella Corneal disease | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Failed Back Surgery Syndrome Subject is at least 18 years old 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Chronic pain following surgical lumbar discectomy for at least 6 months 4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the subjects primary area of pain 6. Subject is able to provide written informed consent Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 2. Escalating or changing pain condition within the past month as evidenced by investigator examination 3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months 5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Subjects with indwelling devices that may pose an increased risk of infection 8. Subjects currently has an active infection 9. Subject has participated in another clinical investigation within 30 days 10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. Subject has been diagnosed with cancer in the past 2 years. 12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Psoriasis Have a diagnosis of generalized chronic plaque and/or guttate psoriasis; 2. Are male and female patients aged between 18 and 75 years inclusive; 3. Have a psoriasis area and severity index (PASI) greater than 7 despite use of topical therapies; 4. Are due to undergo NB-UVB light therapy; 5. Have not required systemic psoriasis therapy during the past eight weeks; 6. Are unlikely to require systemic therapy for the duration of clinical trial involvement; 7. Have a negative pregnancy test at screening (women of child bearing potential only); and 8. Are willing to sign voluntarily a statement of informed consent to participate in the study People with any of the following conditions will be excluded from the study: 1. Photosensitive disorders (lupus erythematosis etc); 2. Diabetes mellitus; 3. Use of medications that can cause photosensitivity; 4. Use of GLP-1 analogue therapy; 5. Conditions that could be made worse by phototherapy (cataract, epilepsy, etc); 6. Allergy or hypersensitivity to Januvia®; 7. Severe kidney disease as defined by a previous diagnosis of chronic kidney disease in the presence of an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73m2; 8. Recent (within 8 weeks) receipt of NB-UVB light; 9. Current or recent (within 8 weeks) use of systemic therapy for psoriasis; 10. Severe heart disease as defined by a previous diagnosis of heart disease and a left ventricular ejection fraction which is known to be less than 35% (as measured by echocardiogram or cardiac catheterisation study); 11. Severe lung disease as defined by a previous diagnosis of chronic lung disease and a forced expiratory volume in 1 second (FEV1) or a forced vital capacity (FVC) that is known to be less than 50% that which would be estimated for a person of that age and gender; 12. Severe liver disease as defined by a previous diagnosis of chronic liver disease in the presence of an alanine transferase concentration greater than 150 international units/L (greater than three times the upper limit of the normal reference range); 13. Any other contraindications to Januvia® as stated in its SPC; 14. Female patients of child bearing potential who are pregnant, breastfeeding, or unwilling to practice an acceptable barrier and/or hormonal method of contraception during participation in the study abstinence will be permitted only if it is in keeping with a person's lifestyle; 15. Any clinically significant chronic disease that might in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial; 16. A current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness or severe uncontrolled/unstable illness; 17. Previous randomisation into this study; 18. Concurrent participation in another clinical trial; and 19. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 20.0-40.0, Hemorrhage of Cesarean Section and/or Perineal Wound Pregnant women aged 20-40 with singleton fetus 38 or more weeks Uncomplicated pregnancy, up to 3rd parity Women undergoing scheduled elective C.S Causes of uterine over-distention such as polyhydramnios or macrosomia Grand multi parity Previous PPH (3 x risk) or previous history of retained placenta Pre-eclampsia or pregnancy-induced hypertension Maternal hypertension Pre-existing maternal hemorrhagic conditions Maternal diabetes mellitus Abnormal placenta Sensitivity to TXA Women taking anticoagulant therapy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation Mitral Regurgitation (1) All patients with asymptomatic chronic, severe primary degenerative MR known to the Queen Elizabeth Hospital Birmingham (of note, the aetiology and severity of MR will be based on the echocardiography findings , interpreted according to the European Association of Echocardiography recommendations) symptoms due to severe MR; 2. LV endsystolic diameter >45mm at baseline; 3. LV ejection fraction <60%; 4. history of myocardial infarction, previous coronary artery bypass graft, or valve surgery; 5. inherited or acquired cardiomyopathy; 6. congenital heart disease; including common atrio-ventricular canal defects; 7. more than mild coexisting aortic valve stenosis or regurgitation 8. primary mitral regurgitation not due to degenerative disease, including rheumatic disease and infective endocarditis; 9. uncontrolled atrial fibrillation (resting HR>100/min average on 24 hour Holter ); 10. unable to undergo CMR; 11. unable to walk on treadmill or use supine bicycle | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Tricuspid (Valve); Deformity all patients 18 years of age or older undergoing minimally invasive, isolated mitral valve annuloplasty concomitant tricuspid valve surgery atrial fibrillation at the moment of surgery poor echocardiographic windows | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-70.0, Heart Septal Defects, Ventricular Double Outlet Right Ventricle, Noncommitted VSD Double Outlet Right Ventricle, Subaortic VSD Double Outlet Right Ventricle, Subpulmonary VSD Supracristal Ventricular Septal Defect (1) patients with single IVSD indicated by TTE，without concomitant cardiac malformation, serious arrhythmia or other important non-cardiac diseases；(2) patients whose ventricular septal defects from aortic residual < 3 mm, preoperative without aortic regurgitation or only mild reflux, defect size ≤10 mm (1) defect size > 10 mm in diameter; （2) Preoperative with above moderate aortic valve prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed consent application | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 22.0-999.0, Mitral Valve Disease in Native Mitral Valve arm All Candidates must meet the following 1. Patient has severe calcific native mitral valve stenosis with mitral annular calcification with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2, or severe mitral regurgitation with severe mitral annular calcification and at least moderate mitral valve stenosis. Qualifying echo must be within 60 days of the date of the procedure. 2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test. 3. The patient is at least 22 years old. 4. The heart team agrees (and verified in the case review process) that valve implantation will likely benefit the patient. 5. The heart team agrees that medical factors preclude operation, based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. Specifically, the STS score is ≥15% or the probability of death or serious, irreversible morbidity is ≥ 50%. The surgeons' consult notes shall specify the medical or anatomic factors leading to that conclusion and a printout of the calculation of the STS score to additionally identify the risks in the patient (some medical factors and definitions are provided below). At least one of the cardiac surgeon assessors must have physically evaluated the patient. All patients must be approved by the Patient Selection and Procedure Management Steering Committee (at least 2 member votes, one must be a cardiac surgeon). 6. The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site. 7. The study patient agrees to comply with all required post-procedure follow-up visits including annual visits through 5 years and analysis close date visits, which will be conducted as a phone follow-up. in Valve-in-Ring arm All Candidates must meet the following 1. Patient has a failing surgical ring in the mitral position with severe mitral regurgitation or stenosis (echocardiographically derived mitral valve area [MVA] of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure. 2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test, or severe hemolytic anemia requiring blood transfusions and no other cause of hemolytic anemia is found after extensive work up. items #3 to 7 will be the same as in Native MV arm described above in Valve-in-Valve arm All Candidates must meet the following 1. Patient has a failing surgical bioprosthesis in the mitral position with severe mitral regurgitation or stenosis with echocardiographically derived mitral valve area (MVA) of ≤1.5 cm2. Qualifying echo must be within 60 days of the date of the procedure. 2. Patient is symptomatic from mitral valve disease, as demonstrated by reported NYHA Functional Class II or greater, or symptoms during stress test. items #3 to 7 will be the same as in Native MV arm described above Candidates will be excluded from the study if any of the following conditions are present: 1. Heart Team assessment of operability (the heart team considers the patient is a surgical candidate). 2. Evidence of an acute myocardial infarction ≤ 1 month (30 days) before the intended treatment [defined as: Q wave MI, or non-Q wave MI with total CK elevation of CK-MB ≥ twice normal in the presence of MB elevation and/or troponin level elevation (WHO definition)]. 3. Mitral annulus is not calcified (only applies to patients included in Native MV arm). 4. Complex untreated coronary artery disease: 1. Unprotected left main coronary artery 2. Syntax score > 32 (in the absence of prior revascularization) 5. Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not excluded. 6. Any patient with a balloon valvuloplasty (BMV) within 30 days of the procedure (unless BMV is a bridge to procedure after a qualifying ECHO). 7. Patients with planned concomitant surgical or transcatheter ablation for Atrial Fibrillation. 8. Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb < 9 g/dL), Thrombocytopenia (Plt < 50,000 cell/mL). 9. Hypertrophic obstructive cardiomyopathy (HOCM). 10. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of screening evaluation. 11. Need for emergency surgery for any reason. 12. Severe ventricular dysfunction with LVEF < 20%. 13. Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 14. Active upper GI bleeding within 3 months (90 days) prior to procedure. 15. A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure. 16. For patients enrolled in the Native MV arm: Native mitral annulus size < 275 mm2 or > 740 mm2 as measured by CT scan. For patients in Valve-in-Ring arm: surgical ring with a true mean internal diameter ≤18 mm or ≥ 29 mm or an area < 275 mm2 or > 740 mm2 as measured by CT scan. Caution recommended in Incomplete bands due to risk of paravalvular leak and risk of LVOT obstruction. Careful measurements by CT and CT-guided procedural planning is recommended Non-circular rigid or semi-flexible rings (e.g., D-shaped, saddle shaped, etc) due to risk of para-valvular leak and/or out of round or incomplete valve expansion. For patients in Valve-in-Valve arm: surgical bioprosthesis with a true internal diameter ≤18 mm or ≥ 29 mm 17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 6 months (180 days) of the procedure. 18. Estimated life expectancy < 24 months (730 days) due to carcinomas, chronic liver disease, chronic renal disease or chronic end stage pulmonary disease. 19. Expectation that patient will not improve despite treatment of mitral stenosis 20. Active bacterial endocarditis within 6 months (180 days) of procedure | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Heart Valve Diseases Mitral Valve Insufficiency Heart; Dysfunction Postoperative, Cardiac Surgery Heart; Disease, Mitral(Valve) Diseases of Mitral Valve Age ≥18 years Male or female from all ethnicities At least 6 months post successful, isolated MV repair. S Asymptomatic Pulmonary hypertension >50 mmHg at rest Atrial fibrillation (AF) at time of study related stress echo test Known contraindication or incapability to perform peak exercise or inability to perform physical stress testing LVEF <45% NYHA class II and more Other heart valve disease of more than mild severity Concomitant surgery during MV repair, e.g. MAZE, TVP procedure Prior heart valve surgery Congenital heart disease Disabling comorbidity, e.g. chronic obstructive pulmonary disease (COPD) | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve or Aortic Valve Replacement The patients who implanted with Perimount Heart Valve (Type: 6900P and 2900) during 2001-2007 in Guangdong General Hospital in China The patients agree to join the study and sign the ICF No specific | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Key Severe mitral regurgitation (MR Grade 3-4+) Symptomatic mitral regurgitation (NYHA Class II-IV) Trans-apical access deemed feasible by the treating physician Native mitral valve geometry and size compatible with the Twelve TMVR Key Left ventricular ejection fraction (LVEF) < 20 Evidence of intracardiac mass, thrombus, or vegetation Prior valve surgery or need for other valve surgery Prior stroke within 4 weeks Need for coronary revascularization History of, or active, endocarditis Renal insufficiency (Creatinine > 2.5 mg/dL) | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation Mitral Valve Prolapse Mitral Valve Insufficiency All subjects referred for mitral valve surgery Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method Age > 18 years Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient committee Degenerative mitral valve disease Subject is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation Women of child-bearing potential have a negative pregnancy test Able to sign informed consent Age < 18 years Infective endocarditis Anterior or bileaflet prolapse Functional mitral regurgitation History of Mediastinal Radiation Inflammatory (rheumatic) valve disease Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.) Symptomatic coronary artery disease Cardiogenic shock at the time of enrollment ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Hypertension, Pulmonary Diseases of Mitral Valve New York Heart Association Functional class (NYHA Fc) ≥ 2 dyspnea which was sustained till one year after the previous mitral valve surgery (repair or replacement) TR Vmax ≥ 3.5m/s by echocardiography Normal left ventricle ejection fraction (EF ≥ 50%) Pulmonary vascular resistance ≥ 3 Wood Unit or diastolic pressure gradient ≥ 7mmHg by cardiac catheterization Other valve disease more than moderate degree (ex. aortic stenosis, aortic regurgitation) Liver cirrhosis Chronic renal failure with serum creatinine ≥ 1.7mg/dL Lung disease (ex. chronic obstructive pulmonary disease, Asthma) Thyroid dysfunction Other causes which can lead to pulmonary hypertension | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Obesity, Severe Cesarean Section Women > 18 years old undergoing cesarean delivery 2. BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission 3. Live gestation 23 weeks or greater 4. Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check Active lupus flare 2. HIV/AIDS 3. Current treatment for cancer or h/o radiation to the abdomen/pelvis 4. Hypersensitivity to steri-strips | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-90.0, Atrial Fibrillation Rheumatic Heart Disease rheumatic mitral valve lesion the absence a history of AF sinus rhythm left atrium size more than 6.0 cm refusal to participate in the study aortic stenosis / regurgitation coronary atherosclerosis | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 50.0-999.0, Aortic Valve Stenosis Age > 50 years 2. Male or female sex 3. Aortic valve area greater than 1.0 cm2 but less than 2.0 cm2 4. Aortic valve calcium levels greater than 300 AU from chest CT 5. Ejection fraction >50% Orthostatic intolerance or symptomatic hypotension prior to study or during study visits 2. Positive pregnancy test during screening visit 3. Nitrate use or α-antagonist medication use within 24 hours 4. Systolic blood pressure <110 mm Hg 5. Mean systemic arterial pressure <75 mm Hg 6. Severe mitral or aortic regurgitation 7. Retinal or optic nerve problems 8. Recent (≤30 days) acute coronary syndrome 9. Oxygen saturation <90% on room air 10. Congenital valve disease 11. Hepatic dysfunction/elevated liver enzymes 12. Prescription of drugs known to alter NO-sGC-cGMP signaling (sildenafil, nitrates, etc.) 13. Prescription of Warfarin (Coumadin) for chronic anticoagulation 14. Concomitant participation in other trials at Mayo Clinic or elsewhere 15. Use of phenytoin or related compounds for any indication 16. Chronic midazolam treatment for any indication 17. Use of monoamine oxidase inhibitors for any indication 18. Use of anti-diabetic drugs in the sulfonylurea family | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 6.0-80.0, Mitral Valve Prolapse MVP diagnosis Signing consent form (By parents if the patient is a minor) Other congenital or acquired cardiac problems other than MVP Patients with other diseases that can affect the exercise capacity | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Diastolic Heart Failure Diastolic Dysfunction Clinical 1. Adult (age > 18 years) 2. Diagnosis of heart failure with preserved ejection fraction 3. NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment. 4. No contraindication for anticoagulation and antiplatelet treatment. 5. Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics) 6. Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment. 7. Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed 8. Patient is able and willing to adhere to the required follow-up visits and testing 9. Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole Echocardiographic 1. Left ventricular ejection fraction≥50% 2. HFpEF diagnosis according to ESC 2016 guidelines 3. No evidence of intra-cardiac thrombus Cardiovascular disease: 1. Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD). 2. Within the past 3 months Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA). 3. History of thrombus within the previous 3 months. 4. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or percutaneous coronary intervention (PCI in the past 3 months or planned/anticipated within the coming 6 months. Patients with mechanical valve replacement or CABG performed more than 3 months before may be eligible for enrollment. 5. Significant valvular disease classified as Moderate or severe aortic stenosis/regurgitation Moderate or severe mitral stenosis Severe mitral regurgitation 6. Hypertrophic cardiomyopathy 7. History of pericardial disease. 8. HF attributed to Cor pulmonale or other cause of isolated right heart failure. 9. Moderate to severe right ventricle failure or right ventricular myocardial infarction. 10. Infiltrative heart disease including amyloidosis. Non-cardiovascular disease: 1. Prior surgery, radiation, or thoracic surgery limiting the ability to place the device. 2. Moderate to severe asthma or COPD, or severe restrictive lung disease. 3. Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2. 4. Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL 5. Severe anemia addressed by Hb concentration <9 gr/l. 6. Solid organ or hematologic transplant. 7. Previous Trans Apical procedures/implantation. Miscellaneous conditions: 1. Co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements. 2. Pregnancy at the time of enrollment. (Women of childbearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices). 3. Participating in another treatment investigational study. 4. A history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the Principal Investigator | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 25.0-90.0, Mitral Valve Insufficiency severe mitral regurgitation symptomatic (NYHA class>1) despite optimal medical therapy suitable anatomy for mitraclip implantation too high risk for cardiac surgery <1 year life expectancy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Insufficiency Heart Valve Disease Cardiovascular Disease Heart Disease Key NYHA Classification ≥ III Left Ventricular Ejection Fraction ≥ 30% Mitral Regurgitation ≥ Grade 3+ Subject meets anatomical and for the investigational device See Protocol | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve or Aortic Valve Replacement The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China The patients agree to sign the inform consent form (ICF) No specific | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Arthroplasty, Replacement, Knee Patients requiring primary TKA, suitable for the use of the Scorpio NRG with X3 insert or Triathlon Total Knee System with X3 insert, or, patients requiring partial knee resurfacing (unicompartmental knee) suitable for the use of the Triathlon PKR (Partial Knee Resurfacing) System with X3 insert 2. Patients who understand the conditions of the outcomes registry and are willing and able to comply with the standard post-operative evaluations and the prescribed rehabilitation. 3. Patients who signed the Informed Consent Form (approved by Ethics Committee if required) prior to surgery None | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-20.0, Child Development children with their families and pregnant women of the area of Leipzig severe diseases | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-90.0, Aortic Valve Stenosis Echocardiography considered as normal and / or age-related Patients who have received prior clinical examination Patient receiving a social security scheme or entitled, or CMU After having giving written informed consent Patients symptomatic with indication of surgery (group surgery) or not With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation Heart valve surgery history (aortic, mitral, tricuspid and pulmonary) Indication for cardiac surgery other than on the aortic valve Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy Patients with severe renal insufficiency with a clearance <30 ml / min estimated by the Cockcroft & Gault formula Patient who cannot be followed over the duration of a year. (healthy volunteers) Normal EKG Echocardiography considered normal and / or age-related Patients who have received prior clinical examination Patient receiving a french national social security | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Mitral Valve Prolapse Patients with mitral regurgitation and mitral valve prolapse who are scheduled for elective mitral valve repair by an experienced mitral valve repair surgeon (>15 degenerative mitral valve repairs per year, with a repair rate>90%, and able to perform mitral repair with either a leaflet resection or leaflet preservation strategy). 2. Planned mitral valve repair amenable to either a leaflet resection or leaflet preservation surgical repair strategy Patients with anterior leaflet or commissural prolapse 2. Patients with endocarditis or rheumatic mitral valve disease 3. Patients with mitral annular calcification extending beyond the circumference of one leaflet scallop 4. Patients with significant LV dysfunction defined as a LVEF <40% 5. Patients undergoing concomitant aortic valve surgery 6. Patients unable to undergo bicycle ergometry | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Hypereosinophilic Syndrome Patient having one of the three following hypereosinophilia> 1500 / mm3, checked on at least two samples (interval between 2 samples at the discretion of the clinician) or hypereosinophilia> 500 cells / mm3 and organ damage with infiltration NCB proven by pathological examination or hypereosinophilia> 500 cells / mm3 and found consistently for at least six months (present on all controls carried out before inclusion). 2. Patient affiliated or beneficiary of a social security system 3. Patient who signed the informed consent Patient with solid tumors known (under chemotherapy or planned) 2. Patient unable to understand or to adhere to the Protocol 3. Patient unable to give consent 4. Pregnant or breastfeeding women 5. Patient already participating in an interventional trial | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 65.0-99.0, Mitral Valve Insufficiency Mitral Regurgitation Prior surgery for degenerative mitral regurgitation (DMR) at Northwestern Memorial Hospital performed by a single surgeon. 2. Male and female ≥ 65 years of age at time of index procedure. 3. Mitral Valve surgery performed > 6 months and <36 months at the time of consent. Concomitant procedures at time of index procedure may incidental CAB, MAZE and tricuspid valve surgery. 4. STS (Society of Thoracic Surgeons) mortality risk score of ≥ 2 and < 6 for mitral valve repair or ≥ 2 and < 8 for mitral valve replacement at time of index procedure. 5. Able to speak, read, and understand English Pre-operative tricuspid regurgitation of 4+ (severe) at time of index procedure. 2. Severe RV Dysfunction. 3. Contraindication to exercise testing (i.e., Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, etc.). 4. Unable to perform an exercise test due to clinical such oxygen dependency, neuromuscular limitations, NYHA class 4, unstable angina, and postural hypotension. 5. Surgical or interventional cardiac procedure or other intervention since the index procedure that in the opinion of the Investigator may confound data analysis. 6. Left ventricular ejection fraction <30%. 7. Subjects unwilling or unable to give written informed consent | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 30.0-85.0, Mitral Valve Insufficiency Presence of symptomatic severe MR (effective regurgitant orifice (ERO) ≥0.2 cm2 for Secondary MR, ERO ≥0.4 cm2 for Primary MR) The New York Heart Association Functional Class II, III or ambulatory IV Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory -Upper Limit of Normal (ULN) Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by TTE obtained within 90 days -Untreated clinically significant coronary artery disease requiring revascularization. Presence of any of the following Estimated pulmonary artery systolic pressure (PASP) > 70 mmHg assessed by site based on echocardiography or right heart catheterization Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis) Hemodynamic instability requiring inotropic support or mechanical heart assistance Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction Coronary artery bypass grafting (CABG) within 30 days prior to subject's consent Percutaneous coronary intervention within 30 days prior to subject's consent Tricuspid valve disease requiring surgery | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-99.0, Pulmonary Edema >= 18 years of age urgent surgery | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mild Tricuspid Regurgitation Moderate Tricuspid Regurgitation Tricuspid Regurgitation Undergoing MVS for degenerative MR with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and trace/mild TR, determined by echocardiography Age ≥ 18 years Able to sign Informed Consent and Release of Medical Information forms Functional MR Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator Structural / organic TV disease Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE) Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG Cardiogenic shock at the time of randomization STEMI requiring intervention within 7 days prior to randomization Evidence of cirrhosis or hepatic synthetic failure Severe, irreversible pulmonary hypertension in the judgment of the investigator | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Heart Failure Symptomatic while on optimal medical therapy (NYHA Class III-IV) Mitral regurgitation of functional etiology Suitable Mitraclip candidate Life expectancy >12 months Mitral regurgitation of primary etiology Refusal to sign the informed consent Dementia or neurological disorders that prevent the proper use of the tablet Inability to use the tablet, the sensors and/or the wearables, even with the assistance of family members Expected non-compliance with follow-up visits End-stage chronic kidney disease on dialysis | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Aortic Valve Stenosis Severe aortic stenosis, defined as follows: 1. For symptomatic patients: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR Maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest 2. For asymptomatic patients Very severe aortic stenosis with an aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND maximal aortic velocity ≥5.0 m/sec , or mean gradient ≥60 mmHg by transthoracic echocardiography at rest, OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND a mean gradient ≥40 mmHg or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND an exercise tolerance test that demonstrates a limited exercise capacity, abnormal BP response, or arrhythmia OR Aortic valve area of ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), AND mean gradient ≥40 mmHg, or maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest, AND a left ventricular ejection fraction <50%. 2. Documented heart team agreement of low risk for SAVR, where low risk is defined as predicted risk of mortality for SAVR <3% at 30 days per multidisciplinary local heart team assessment. 3. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits Any condition considered a contraindication for placement of a bioprosthetic valve (eg, subject is indicated for mechanical prosthetic valve). 2. A known hypersensitivity or contraindication to any of the following that cannot be adequately pre-medicated: 1. aspirin or heparin (HIT/HITTS) and bivalirudin 2. ticlopidine and clopidogrel 3. Nitinol (titanium or nickel) 4. contrast media 3. Blood dyscrasias as defined: leukopenia (WBC <1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 4. Ongoing sepsis, including active endocarditis. 5. Any percutaneous coronary or peripheral interventional procedure with a bare metal stent within 30 days prior to randomization, or drug eluting stent performed within 180 days prior to randomization. 6. Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery. 7. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 8. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 9. Recent (within 2 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 10. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 11. Subject refuses a blood transfusion. 12. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits). 13. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions. 14. Other medical, social, or psychological conditions that in the opinion of the investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams. 15. Currently participating in an investigational drug or another device trial (excluding registries). 16. Evidence of an acute myocardial infarction ≤30 days before the trial procedure due to unstable coronary artery disease (WHO criteria). 17. Need for emergency surgery for any reason. 18. Subject is pregnant or breast feeding. 19. Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable 20. Pre-existing prosthetic heart valve in any position. 21. Severe mitral regurgitation amenable to surgical replacement or repair. 22. Severe tricuspid regurgitation amenable to surgical replacement or repair. 23. Moderate or severe mitral stenosis amenable to surgical replacement or repair. 24. Hypertrophic obstructive cardiomyopathy with left ventricular outflow gradient. 25. Bicuspid aortic valve verified by echocardiography, MDCT, or MRI. 26. Prohibitive left ventricular outflow tract calcification. 27. Sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis. 28. Aortic annulus diameter of <18 or >30 mm. 29. Significant aortopathy requiring ascending aortic replacement. For transfemoral or transaxillary (subclavian) access: 30. Access vessel mean diameter <5.0 mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <5.5 mm for Evolut 34R mm or Evolut PRO TAV. However, for transaxillary (subclavian) access in patients with a patent LIMA, access vessel mean diameter <5.5mm for Evolut 23R, 26R, or 29R mm TAV, or access vessel mean diameter <6.0 mm for the Evolut 34R or Evolut PRO TAV | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Insufficiency Cardiac Valve Annuloplasty Mitral Valve Annuloplasty Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Regurgitation Age ≥18 years 2. Severe (3+ to 4+) secondary Mitral Regurgitation 3. Symptomatic heart failure (NYHA Class III-IVa) despite guideline directed medical therapy including CRT if indicated 4. The Local Site Heart Team concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy. 5. Transfemoral access and transseptal deployment of the Cardioband is determined to be feasible 6. Subject is willing and able to provide informed consent and follow protocol EF < 20% 2. LVEDD ≥ 70 mm 3. Heavily calcified annulus or leaflets 4. Significant CAD requiring revascularization 5. Active bacterial endocarditis 6. Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months 7. Renal insufficiency requiring dialysis 8. Life expectancy of less than twelve months 9. Subject is participating in concomitant research studies of investigational products that have not reached their primary endpoint 10. Pulmonary hypertension ≥ 70mmHg at rest 11. Mitral valve anatomy which may preclude proper device treatment 12. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and/or severe tricuspid regurgitation 13. Severe liver disease 14. Patient is pregnant or lactating 15. Hypersensitivity to Nickel or Chromium 16. Clinically significant bleeding diathesis or coagulopathy 17. History of mitral valve repair 18. TIA or CVA within 3 months | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Valve Regurgitation (Degenerative or Functional) Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical Unsuitable anatomy Patient is inoperable | 2 |
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