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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): 18.0-999.0, Mitral Valve Regurgitation Symptomatic ≥3+ degenerative or functional mitral regurgitation of either ischemic or non-ischemic etiology based by a qualifying echocardiography obtained within 90 days prior to the procedure New York Heart Association (NYHA) Functional Class III or IV High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team Left Ventricular Ejection Fraction (LVEF) is ≥30% within 30 days prior to the procedure Mitral valve annular commissure to commissure (C/C) dimension between 30-35 mm by echocardiography Left atrial diameter <5.5 cm by echocardiography Prior mitral valve replacement or repair surgery Prior transapical surgery Severe aortic or tricuspid valve disease Severe symptomatic carotid stenosis (>70% by ultrasound) ACC/AHA Stage D heart failure 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 (amyloidosis, hemochromatosis, sarcoidosis) Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction Severe mitral annular calcification Glomerular filtration rate (GFR) < 30 | 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 NYHA ≥ II Moderate/severe or severe mitral regurgitation Prohibitive risk for open-heart surgery Meets anatomical Unsuitable anatomy Need for emergent or urgent surgery Prior mechanical aortic valve replacement Any prior surgical or transcatheter repair (excluding balloon valvuloplasty) or replacement of the mitral valve Preexisting device in the left ventricular apex Clinically significant, untreated coronary artery disease Limited life expectancy (< 12 months) Active infection | 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, Aortic Valve Stenosis Heart Valve Diseases Aortic Valve Disease ≥ 18 years of age Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 or mean gradient greater than 40 mmHg by echocardiography or double lesion with predominant stenosis Referred for medically indicated aortic valve replacement Provide written informed consent Left ventricular ejection fraction less than 0.40 Presence of any coexisting severe valvular disorder Previous cardiac surgery Urgent or emergent surgery Infective endocarditis Need for concomitant procedures other than isolated myectomy Severe COPD Severe thorax deformity | 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, Metastatic Pancreatic Cancer Must have histologic or cytologic confirmation of recurrent metastatic pancreatic adenocarcinoma based on standard diagnostic criteria. Recurrence must be documented by diagnostic biopsy Have measurable disease as defined by Response Evaluation in Solid Tumours (RECIST) version 1.1 Have had disease progression, been refractory or intolerant to no more than 2 prior systemic regimens for locally advanced or metastatic pancreatic cancer. Participants who have received prior neoadjuvant therapy and who now have metastatic disease must have received 1 of the following for their metastatic disease: nanoparticle albumin-bound paclitaxel/gemcitabine, TS-1 (tegafur gimeracil oteracil potassium), irinotecan liposome injection/5-fluorouracil (5FU)/Leucovorin or single-agent gemcitabine prior to enrolment in this study Dose Escalation: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment) or to provide an available archival tumour sample if taken <3 years prior to enrolment if a new tumour biopsy is not feasible with an acceptable clinical risk Cohort Expansion: Able and willing to give valid written consent to undergo a new tumour biopsy (prior to study treatment). Able and willing to undergo a second tumour biopsy on treatment. Where possible, tumour lesions used for new biopsies should not be the same lesions used as target lesions, unless there are no other lesions suitable for biopsy. Archival samples may be required if there is inadequate tissue in the biopsy specimen Have adequate organ function Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale Use approved contraceptive methods Have moderate or severe cardiovascular disease Have the presence of cardiac disease, including a myocardial infarction within 6 months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension Have documented major electrocardiogram (ECG) abnormalities (not responding to medical treatments; for example, atrial fibrillation, bundle branch blocks, or as approved by the sponsors) Have major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation, left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal, septal aneurysm or other heart aneurysm, any aneurysm of the major vessels or any condition that results in increased risk of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]) Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography [CT] scan with contrast or magnetic resonance imaging [MRI]) Have evidence of interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity or active, noninfectious pneumonitis | 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 Valve 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. Subjects with low-flow/low gradient severe aortic stenosis can be included, provided low-dose dobutamine or exercise stress echocardiography demonstrates a mean gradient of > 40 mmHg or a maximal aortic valve velocity of > 4.0 m/sec, AND aortic valve area of < 1.0 cm2 (or aortic valve area index of < 0.6 cm2/m2). 2. Society of Thoracic Surgeons (STS) score of ≥ 8 OR documented heart team agreement of ≥ high risk for aortic valve replacement due to frailty or co-morbidities. 3. Symptoms of aortic stenosis, AND New York Heart Association (NYHA) Functional Class II or greater. 4. 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 (e.g. subject is indicated for mechanical prosthetic valve). 6. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated aspirin or heparin (HIT/HITTS) and bivalirudin ticlopidine and clopidogrel Nitinol (titanium or nickel) contrast media 7. Blood dyscrasias as defined: leukopenia (WBC < 1000 mm3), thrombocytopenia (platelet count <50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states. 8. Untreated clinically significant coronary artery disease requiring revascularization. 9. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20% by echocardiography, contrast ventriculography, or radionuclide ventriculography. 10. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min. 11. Ongoing sepsis, including active endocarditis. 12. Any percutaneous coronary or peripheral interventional procedure with a bare metal or drug eluting stent performed within 30 days prior to study procedure. 13. Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 10 weeks of Heart Team assessment. 14. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support. 15. Recent (within 6 months of Heart Team assessment) cerebrovascular accident (CVA) or transient ischemic attack (TIA). 16. Gastrointestinal (GI) bleeding that would preclude anticoagulation. 17. Subject refuses a blood transfusion. 18. 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). 19. Estimated life expectancy of less than 12 months due to associated non-cardiac co-morbid conditions. 20. 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. 21. Currently participating in an investigational drug or another device study (excluding registries). 22. Evidence of an acute myocardial infarction ≤ 30 days before the study procedure. 23. Need for emergency surgery for any reason. 24. Liver failure (Child-Pugh class C). 25. Subject is pregnant or breast feeding. Anatomical Pre-existing prosthetic heart valve in any position. 27. Mixed aortic valve disease (aortic stenosis with severe aortic regurgitation). 28. Severe mitral regurgitation. 29. Severe tricuspid regurgitation. 30. Moderate or severe mitral stenosis. 31. Hypertrophic obstructive cardiomyopathy. 32. Echocardiographic or Multi-Slice Computed Tomography (MSCT) evidence of intracardiac mass, thrombus, or vegetation. 33. Congenital bicuspid or unicuspid valve verified by echocardiography. For transfemoral or transaxillary (subclavian) access: 34. Access vessel diameter < 5.5 mm or <6.0 mm for patent left internal mammary artery (LIMA) | 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, Heart; Decompensation, Right Ventricle Echocardiography Hypercapnia scheduled mitral valve prolapse repair surgery able to give informed consent preoperative right ventricular dysfunction or pulmonary hypertension significant tricuspid regurgitation congenital heart defect ventricular dyssynchrony or wide QRS-complex on ECG (> 130 ms) prior myocardial infarction (within tree months) or pericardial constriction preoperative left ventricular (LV) dysfunction, i.e. LV ejection fraction under 40 % if the scheduled repair by plastic procedure has been converted to mitral valve replacement | 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): 50.0-85.0, Heart Valve Diseases Coronary Artery Disease Patient indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours. 2. Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG). 3. The patient is >50 and <85 years of age. 4. The patient's body weight is compatible with blood net flow of 4 [l/min]. 5. Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA) 6. The patient is willing to participate as evidenced by signing the written informed consent. 7. Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test) Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal. 2. Patient with an aortic trauma. 3. Patient contraindicated for open heart surgery under bypass machine. 4. Patient undergoing a re-do procedure. 5. Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy) 6. Patient with pathologies which affect his/her neurological condition. 7. Patient in whom emergency operation is required. 8. Patient with a known allergy to Heparin 9. Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to previous stroke critical preoperative state poor ventricular function severe pulmonary hypertension [19] Atheroembolism history of cardiac failure [20] 10. Current use of drugs that might result in high surgical risk or significant postoperative complication. 11. Psychological instability, inappropriate attitude or motivation. 12. Patients with life threatening debilitating disease other than cardiac. 13. Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints | 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 Has severe mitral regurgitation New York Heart Association (NYHA) Class II, III, IVa or heart failure High risk for cardiovascular surgery Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass Left ventricular end diastolic dimension > 7cm Left ventricular outflow tract obstruction Severe right ventricular dysfunction Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index 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): 18.0-999.0, Mitral Valve Regurgitation Mitral Valve Prolapse Mitral Valve Insufficiency Age ≥ 18 years Patient referred for mitral valve surgery Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient committee Degenerative mitral valve disease Patient 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 Age < 18 years Infective endocarditis Anterior or bileaflet prolapse Functional MR 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): 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): 21.0-999.0, Mitral Valve Insufficiency Is a candidate for mitral valve repair with cardiopulmonary bypass Has Grade III moderate or Grade IV severe degenerative mitral valve regurgitation Primary segmental prolapse of the A2 or P2 segment or prolapse extending to an adjacent segment (P1, P3, A1, A3) who have a single eccentric regurgitant jet on echocardiogram Anterior leaflet covers at least 65% of anterior-posterior annular distance or an anterior leaflet that would provide sufficient coaptation after chord placement Anatomic and general suitability Prior mitral valve surgery Concomitant cardiac procedures Other cardiac procedures within 3 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): 20.0-999.0, The Episodes of Gastric Regurgitation Patients who will receive scheduled surgery under SAD-based general anesthesia 2. Aged >= 20 Major systemic disease, such as congestive heart failure, liver cirrhosis, end stage renal disease and malignancy. 2. Patients who have the risk of difficult ventilation or intubation. 3. pregnant women 4. prior nasal surgery or trauma 5. current use anticoagulant or antiplatelet agents 6. coagulopathy | 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): 21.0-60.0, Marfan's Syndrome Patient that are under the care of the cardiologist and diagnosed with Marfan's syndrome or who had underwent Fontan palliation | 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): 20.0-79.0, Type B Aortic Dissection a) In case of acute Type B dissection (14 days from first dissection) Maximum aortic diameter >40 mm or Increase in aortic diameter >2 mm from baseline b) In case of subacute (15~90 days) or chronic (90 days ~ 1 year) Type B Maximum aortic diameter >55 mm or Increase in aortic diameter >4 mm from baseline 2. Age 19-80 years. 3. Aorta anatomy appropriate for stent graft therapy, 1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed. 2. Proximal landing zone length >20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta. 4. Declaration of voluntary participation in the study with signed informed consent form Endorgan ischemia or evidence of malperfusion due to aortic dissection 2. Aortic rupture or impeding rupture due to aortic dissection 3. Renal dysfunction with serum Cr level >2.0 mg/dL 4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases 5. Uncontrolled active infection or active vasculitis. 6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment. 7. Previous thoracic aorta surgery or stent-graft implantation 8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment. 9. Women with positive pregnancy test or at child bearing age 10. Life expectancy <1 year due to comorbidity | 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, Cardiovascular Diseases Severe primary mitral regurgitation (grade 3+ or 4+) Class I indication for MV Surgery according to ESC/EACTS and AHA/ACC guidelines: 1. Symptomatic patients and/or 2. LV (Left Ventricular) dysfunction : LVESD ≥45 mm and/or 30≤ LVEF ≤60% Leaflet prolapse of P2 and/or A2 Predicted coaptation length > 4 mm Candidates for surgical mitral valve repair according to heart team Patient able to sign an informed consent form Patient benefiting from a social insurance system or a similar system Asymptomatic patients with preserved LV function Complex mechanism of MR (leaflet perforation, severe calcifications, commissural extension, etc) Secondary MR Predicted post-repair coaptation length less than 4 mm Atrial fibrillation Inflammatory or infective valve disease Severe LV dilation (DTD > 65 mm) Significant mitral annulus dilatation (D > 45 mm) Surgical indication of tricuspid annulus Contraindication to TEE (transesophageal echocardiographic ) or inadequate image quality | 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): 22.0-999.0, Mitral Annular Calcification Subject has severe native mitral annular calcification associated with mitral stenosis and/or regurgitation. Qualifying echo must be within 60 days of the date of the procedure Subject has a clinical indication for mitral valve replacement, as demonstrated by reported New York Heart Association (NYHA) Functional Class II or greater The subject is at least 22 years old The Heart Team agrees that the subject is high risk or inoperable for surgical mitral valve repair or replacement (MVR), based on a conclusion that the probability of death or serious, irreversible morbidity exceeds the probability of meaningful improvement. The following concomitant procedures, are allowed: MAZE, Tricuspid Valve Procedures (TVP), and Atrial Fibrillation (AF) ablation, coronary artery bypass grafting and septal myectomy The study subject 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 The study subject agrees to comply with all required post-procedure follow-up visits Evidence of an acute myocardial infarction (MI) ≤ 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)] 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) Leukopenia (white blood cell count < 2000 cell/mL), acute anemia (hemoglobin < 8 g/dL), or thrombocytopenia (platelet count < 50,000 cell/mL) Hemodynamic or respiratory instability requiring vasoactive medications, mechanical ventilation at time of procedure Need for emergency surgery for any reason Severe left ventricular dysfunction with Left Ventricular Ejection Fraction (LVEF) < 30% Severe right ventricular dysfunction Pregnancy, lactation, or planning to become pregnant Echocardiographic evidence of left ventricular mass, thrombus, or concerns of active infective endocarditis Active upper gastrointestinal (GI) bleeding within 3 months prior to procedure without treatment or 30 days prior to procedure with definitive treatment | 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): 0.0-15.0, Retrograde Femoral Catheterism requirement of retrograde femoral arterial catheterism 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 Prolapse Mitral valve prolapse diagnosed in echocardiography Signed written consent Affiliation to social security No contraindication to MRI or exercise ECG Age above 18 Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery Prior MRI with contrast within the last month Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis Contraindication to exercise ECG: severe handicap, poor physical capacity Contraindication to MRI: implantable device, claustrophobia, metal debris Renal insufficiency with creatinine clearance <30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent Pregnant or breast-feeding women Minors <18 years old Mental illness or incapacity with incapacity to obtain informed consent | 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, Bicuspid Aortic Valve bicuspid aortic valve, confirmed by transthoracic or transesophageal echocardiography With or without an aneurysm of the ascending thoracic aorta nonsyndromic aortic syndromic pathology antecedent of acute articular rhumatism | 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): 1.0-80.0, Data Collecting and Analyzing of Different Treatment of Structural Heart Diseases atrial septal defect 20ventricular septal defect 3.patent ductus arteriosis 4.pulmonary stenosis 5.residual leakage after surgical treatment for congenital heart disease 6.coronary artery fistula 7.pulmonary arteriovenous malformations 8.tetralogy of Fallot, and other cyanotic heart disease 9.mitral stenosis and insufficiency 10.tricuspid stenosis and insufficiency 11.aortic stenosis and insufficiency 12.pulmonary stenosis and insufficiency 13.coarctation of aorta 14.paravalvular leakage 15.hypertrophic obstructive heart disease 16.dilated cardiomyopathy 17.structural heart disease need surgery combined with interventional hybrid treatment 18.structural heart disease need surgeryor interventional treatment primary arrhythmia cardiac disease,like tachycardia and ventricular fibrillation 2. circulation disease, like coronary heart disease,hypertension,arterial aneurysm 3. patients were not received any treatment 4. patients were hard to follow-up 5. no informed Consent | 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 Males or females, 18 years of age or older. 2. Negative pregnancy test (serum or urine β-HCG) within 24 hours of gadolinium contrast administration, if female and of child-bearing potential. In addition, all female patients of childbearing potential must agree to use a medically accepted method of contraception throughout the study (this applies only to patients in the gadolinium sub-study). 3. Symptomatic severe mitral regurgitation (grade 3-4+). 4. Undergoing MitraClip implantation due to increased surgical risk. 5. Patients or legally authorized representatives who have the ability to understand the requirements of the study and provide written consent/assent to participate and agree to abide by the study requirements The patient is enrolled in the Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial (COAPT). 2. The patient is scheduled to undergo percutaneous coronary intervention with MitraClip procedure. 3. The patient has Stage D Congestive Heart Failure or inability to lay flat for 60 minutes. 4. The patient has a medical condition, serious concurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up. 5. The patient has contraindications to CMR, including: 1. Implanted defibrillator or pacemaker that is not MRI conditional 2. Epicardial pacemaker leads, or any abandoned leads 3. Ferromagnetic aneurysm clip 4. Ferromagnetic halo device 5. Cochlear implants 6. Implanted infusion pumps 7. Severe claustrophobia 8. Any other conditions which represent contraindication to CMR. 6. The patient is clinically unstable | 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 Disease Aged over 18 years Presenting with severe mitral valve stenosis or regurgitation regardless of etiology (primary mitral regurgitation, secondary mitral regurgitation, deterioration of mitral valve repair or bioprosthesis, mitral annular calcification) Symptomatic (NYHA functional class II-IV) despite optimized medical therapy Judged not eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist Having received information about the study and not expressing opposition to the use of their data Patient not included in a clinical trial Asymptomatic patients Absence of severe mitral regurgitation or stenosis Patient judged eligible for surgical treatment according to a specialized multidisciplinary meeting called "heart team" comprising at least one cardiothoracic surgeon, one interventional cardiologist, one echocardiographer, one clinical cardiologist and one anaesthesiologist Pregnant or breastfeeding women Having not received information about the study or having expressed opposition to the use of their data | 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): 18.0-95.0, Mitral Valve Regurgitation Organic mitral valve regurgitation with effective regurgitation orifice (ERO)>0.3 cm2 Age > 18 years Left ventricular ejection fraction (LVEF) > 60% assessed by echocardiography Signed informed consent Poor echocardiographic window Inability to perform bicycle exercise testing Ischemic or functional (secondary) mitral valve regurgitation Chronic atrial fibrillation/flutter Hemodynamic significant aortic valve disease assessed by echocardiography Treatment with oral anticoagulants | 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, Tricuspid Disease Mitral Regurgitation age > 18 years ability to provide informed consent patients scheduled for mitral valve regurgitation TR ≤ 2+ with annular dilation Tricuspid diastolic diameter ≥ 40 mm or 21 mm/m2 patient's refusal non-elective cardiac surgery organic disease of tricuspid valve TR≥3 | 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 Insufficiency Age 18 years and older Able to give informed consent Undergoing lone mitral valve surgery for chronic primary mitral regurgitation within 30 days Indication for mitral valve surgery is a class I or IIa according to the 2014 ACC/AHA guidelines for the management of valvular heart disease Secondary mitral regurgitation Have a device which is not compatible with MRI Claustrophobia preventing MRI Concomitant CABG, other valve surgery, or other cardiac surgery Atrial fibrillation or other substantial arrhythmia that would substantially degrade MRI image acquisition | 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, Atrial Fibrillation Age 18+ on index date Patients must have been prescribed either dabigatran, rivaroxaban, or apixaban identified by pharmacy claim during the study period. The first dispensing date of either study drug will be defined as the index date Patients must be treatment naïve from all OAC use prior to the first NOAC prescription, during study period Patients must have at least 12 months of continuous prior to the index date Patients must have at least one diagnosis code of atrial fibrillation, defined as International Classification of Diseases (ICD)-9-CM diagnosis of 427.31 or ICD-10-CM diagnosis of I48.0, I48.1, I48.2, I48.91 on the index date or during the pre-index period Less than 12 months of continuous in the pre-index period Any claim for OAC drug (oral use only) in the pre-index period Diagnosis of hyperthyroidism during the pre-index period Having at least one claim for alternative indications; orthopedic procedures, Venous thromboembolism (VTE) (includes deep vein thrombosis (DVT ) & PE)) and the index NOAC prescription at the same time, or, the alternative indication for anticoagulant occurring within 3 months prior to index date in pre-period Having at least one claim with any of the following diagnoses or procedure codes in order to patients with "transient" causes of Afib (3 months prior to index date in pre-period) Cardiac surgery Pericarditis Myocarditis Having at least one medical claim with any of the following diagnoses or procedures codes in order to patients with "valvular" Afib (pre-period) Mitral stenosis Mitral stenosis with insufficiency Mitral valve stenosis and aortic valve stenosis Mitral valve stenosis and aortic valve insufficiency Diseases of other endocardial structures Other and unspecified rheumatic heart 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): 0.0-999.0, Mitral Regurgitation Ischemic cardiomyopathy Ischemic mitral regurgitation Degenerative mitral valve disease Unstable angina Recent myocardial infarction (< 6 months) Papillary muscles rupture Severe right ventricular dysfunction Multiple organ failures Concomitant left ventricular reconstruction Aortic valve procedures | 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 High surgical risk for open mitral valve surgery Subject meets anatomical Deemed too frail by objective frailty assessments Previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant Unsuitable cardiac structure Clinically significant untreated Coronary Artery Disease (CAD) Subjects on chronic dialysis Pregnant or planning pregnancy within next 12 months Documented bleeding or coagulation disorders Active infections requiring antibiotic therapy Subjects with a life expectancy less than 12 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): 18.0-999.0, Aortic Valve Stenosis Subject has provided written informed consent prior to uploading CT scan to core lab. 2. Subject is ≥ 18 years of age or legal age in host country. 3. Subject's aortic annulus diameter meets the range indicated in the Instructions for Use as measured by multislice CT conducted within 180 days prior to the index procedure. 4. Subject has senile degenerative aortic stenosis seen by echocardiography within 90 days of index procedure as measured by: 1. mean gradient >40 mmHg 2. Peak velocity ≥ 4.0 m/s 3. Doppler Velocity Index <0.25 4. Aortic valve area (AVA) of ≤ 1.0 cm2 or indexed EOA ≤ 0.6 cm2/m2). 5. Subject has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of Class II, or greater or other symptoms of aortic stenosis (e.g. syncope). 6. Subject is deemed high operable risk and preferred TAVI delivery route is alternate access (subclavian/axillary or direct aortic) per the medical opinion of the center's heart team and confirmed by SSC High risk is defined as an STS mortality > 8% or documented heart team agreement ≥ high risk for SAVR due to frailty or co-morbidities 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 carotid artery disease requiring intervention. 4. Subject has evidence of a myocardial infarction (MI) within 30 days prior to patient index procedure. 5. Subject has a native aortic valve that is congenitally unicuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Subject has severe mitral valvular regurgitation. 7. Subject has severe mitral stenosis. 8. Subject has a pre-existing prosthetic cardiac device, valve, or prosthetic ring in any position. 9. Subject refuses any blood product transfusion. 10. Subject has resting left ventricular ejection fraction (LVEF) less than 20%. 11. Subject has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization. 12. Subject has had a percutaneous interventional or other invasive cardiovascular or peripheral vascular procedure less than or equal to 14 days prior to index procedure. 13. Subject has severe basal septal hypertrophy that would interfere with transcatheter aortic valve placement. 14. Subject has a history of, or is currently diagnosed with, endocarditis. 15. There is imaging evidence of intracardiac mass, thrombus, or vegetation. 16. Subject is considered hemodynamically unstable (requiring inotropic support or mechanical heart assistance). 17. Subject is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 18. Subject with severe pulmonary disease as determined by STS score. 19. Subject is on chronic oral steroid therapy. 20. Subject has a documented hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Subject has renal insufficiency as evidenced by a serum creatinine greater than 3.0 mg/dL (265.5 µmol/L) or end-stage renal disease requiring chronic dialysis. 22. Subject has morbid obesity defined as a BMI greater than or equal to 40. 23. Subject has ongoing infection or sepsis. 24. Subject has uncontrolled blood dyscrasias as defined: leukopenia (WBC<3000 mm3), acute anemia (Hb<9 mg/dL), thrombocytopenia (platelet count <50,000 cells/mm3,). 25. Anatomy falling outside the recommended values in the IFU, unless specifically approved by the Subject Selection Committee. 26. Subject has an active peptic ulcer or has had gastrointestinal (GI) bleeding within 90 days prior to the index procedure. 27. Subject is currently participating in another investigational drug or device study, unless approved by the Sponsor. 28. Subject has/had emergency surgery for any reason within 30 days of the index procedure. 29. Subject has a life expectancy less than 1 year. 30. 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. 31. Subject is diagnosed with a state of dementia which would fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits. 32. Subject has a documented allergy to contrast media that cannot adequately be treated, nitinol alloys, porcine tissue, or bovine tissue. 33. Significant aortic disease including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater 34. Subjects with severe pulmonary hypertension and severe RV dysfunction 35. Subjects with hypertrophic cardiomyopathy Transaortic Subject Cohort Specific Subjects are not eligible for participation in the TAo access arm if they meet any of the following Subject has a chest condition (anatomical or otherwise) that prevents TAo access. 2. Subject has pre-existing patent RIMA graft that would preclude access. 3. Subject has a porcelain aorta, defined as an extensive circumferential calcification of the ascending aorta that would complicate TAo access. Subclavian/Axillary Subject Cohort Specific Subjects are not eligible for participation in the subclavian/axillary access arm if they meet any of the following Subject's access vessel (subclavian/axillary) diameter will not allow for introduction of the 18/19 Fr delivery system. 2. Subject's subclavian/axillary arteries have severe calcification and/or tortuosity. 3. Subject has a history of LIMA/RIMA graft that would preclude access | 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 Coronary Artery Disease Randomized patients in the MMR and SMR trials who were still alive at 2 years after the index cardiac surgical intervention Patients participating in the MMR and SMR trials who withdrew consent prior to the 2-year follow-up evaluation | 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 valve regurgitation transcatheter mitral valve repair no written informed consent | 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 Acute Myocardial Infarction Patient ≥ 18 year-old Transmural myocardial infarction in the previous 4 weeks (managed under current guideline's recommendations) Symptomatic severe mitral regurgitation diagnosed by left ventriculography, transthoracic echo or trans-oesophageal echo. Symptoms may vary form heart failure to cardiogenic shock Symptoms should be stabilized by medical management: iv diuretics, inotropic support, LV assistance devices Considered by heart team at high risk for conventional surgery Anatomy not suitable for MitraClip implantation Technical contraindication for access to left atrium Patient candidate for emergent heart transplant Uncontrolled infection | 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, Tricuspid (Valve) Insufficiency (Rheumatic) Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection 1. Written informed consent 2. Degenerative mitral valve disease 3. > 18 years old Main Presence of structural or organic tricuspid valve disease 2. urgent operation 3. presence of pacemaker leads through the tricuspid annulus 4. acute endocarditis or other organic valve diseases 5. previous surgical procedure 6. Severe TR 7. Associated cardiac procedure 8. NYHA class IV 9. Severe COPD (GOLD class 3,4) | 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, Functional Mitral Regurgitation Heart Failure Mitral Valve Insufficiency Heart Diseases Cardiovascular Diseases Heart Valve Diseases Diagnosis of ischemic or non-ischemic cardiomyopathy 2. Symptomatic functional (secondary) mitral regurgitation defined as both (Moderate), 3+ (Moderate/Severe), or 4+ (Severe). Note: 4+ can only be included if multidisciplinary site assessment (including a surgeon) determines that surgery is not necessary within the 1-year follow-up period for this study. 3. NYHA Class II, III, or IV 4. Six Minute Walk distance ≥ 150 meters and ≤ 450 meters 5. Left Ventricular Ejection Fraction ≤ 50% 6. LVESD ≤ 70 mm Note: As assessed by Imaging Core Laboratory. 7. Corrected BNP of > 300 pg/ml, or corrected NT-proBNP > 1500 pg/ml, or one or more heart failure hospitalizations within one year prior to consent 8. Guideline directed heart failure medication regimen. 9. Age ≥ 18 years old 10. implant can be sized and placed in accordance with the IFU 11. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent Recipient of intravenous positive-inotrope infusion or intra-aortic balloon pump support within the past 30 days 2. Heart failure hospitalization within the past 30 days 3. Anticipated need of left ventricular assist device within twelve (12) months 4. Class I indication for cardiac resynchronization therapy (CRT), or anticipated need for CRT within twelve (12) months 5. Primary renal dysfunction or compromised renal function as reflected by an estimated Glomerular Filtration Rate (eGFR) < 30 ml/min, as assessed by MDRD formula, or patients on dialysis 6. Heart transplant candidate or prior orthotopic heart transplantation 7. Presence of a mechanical or bio-prosthetic mitral valve or, mitral valve annuloplasty, or leaflet repair device. 8. Hypertrophic cardiomyopathy, infiltrative cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis 9. Echocardiographic documentation of non-compaction cardiomyopathy as assessed by the Imaging Core Laboratory 10. Pre-existing device (e.g., pacing lead) in coronary sinus (CS) / great cardiac vein (GCV) 11. Significant organic mitral valve pathology (e.g., moderate or severe myxomatous degeneration, with or without mitral leaflet prolapse, rheumatic disease, full or partial chordal rupture), as assessed by the Imaging Core Laboratory 12. Severe tricuspid regurgitation associated with right ventricular dysfunction and enlargement, as assessed by the Imaging Core Laboratory 13. Severe mitral annular calcification 14. Severe aortic stenosis 15. Not a candidate for right internal jugular venous cannulation 16. Hospitalization in past 30 days due to myocardial infarction, coronary artery bypass graft surgery or unstable angina 17. Cerebral vascular event within the past 30 days 18. Hospitalization in the past 30 days for coronary angioplasty or stent placement or ICD implant 19. Pulmonary embolus or deep vein thrombosis within the past six (6) months 20. Expected to require any cardiac surgery, including surgery for coronary artery disease (CAD) or valve disease within one (1) year 21. Expected to require any percutaneous coronary intervention within 30 days of the index procedure. 22. Hemodynamic instability defined as sustained systolic blood 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 23. Presence of left atrial appendage (LAA) clot or presence of LAA occluder 24. Anemia defined as hemoglobin < 9.0 mg/dL 25. Currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints 26. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically 27. Active infections requiring current antibiotic therapy 28. Chronic, severe, medical conditions or pathology, other than heart failure, that will prevent likely survival beyond twelve (12) months 29. Female subjects pregnant or planning to become pregnant in the next five (5) years 30. Subjects unable to perform the required study assessments (e.g., 6 minute walk test) 31. Any other medical condition that, in the judgment of the Investigator, makes the patient a poor candidate for this study 32. Subjects belonging to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or comply with the study procedures | 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 Pulmonary Hypertension symptomatic, severe mitral regurgitation referral for diagnostic work-up and heart team discussion declaration of informed consent contra-indication for cardiopulmonary stress examination (unstable angina pectoris, left main disease, abnormal electrolyte concentrations, acute decompensation) pregnancy exercise test on treadmill not possible (amputation of lower extremity, severe arthritis of lower extremities) no acceptable acoustic window at rest | 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): 18.0-85.0, Mitral Regurgitation Pulmonary Hypertension Patients listed for surgery for severe primary mitral regurgitation +/ concomitant coronary artery bypass grafting for bystander disease +/ tricuspid valve surgery +/- atrial fibrillation surgery Secondary mitral regurgitation. Significant history of ischaemic heart disease eg. angina. Age <18 years or >85 years. Critical preoperative status with multi-organ dysfunction. Emergency cardiac surgical intervention. Pregnancy. Unable to give informed consent or unwilling to participate in research. Patients with definite contraindication for MRI would be excluded from the cardiac MRI element of the study. Patients we are unable to take adequate biopsies due to technical difficulties would be excluded from the myocardial biopsy element of the study | 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): 75.0-999.0, Aortic Valve Stenosis Patient with severe symptomatic aortic stenosis defined by a mean aortic gradient > 40 mmHg or peak jet velocity > 4.0 m/s or an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of <0.6 cm2/m2 Patient is symptomatic (heart failure with New York Heart Association (NYHA) Functional Class > I, angina or syncope) Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of a cardiologist and surgeon or as confirmed by a logistic EuroSCORE I > 20% and / or STS score > 10% Aortic annulus diameter ranging from 21 to 26mm and perimeter rage from 66 7mm , based on ECG-gated multi-slice computed tomographic measurements. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment Arterial aorto-iliac-femoral axis suitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter ≥ 6mm) Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up Patient age 75 years or older Patient has given written consent to participate in the trial Severely reduced left ventricular (LV) function (ejection fraction <20%) Pre-existing prosthetic heart valve in aortic and/or mitral position Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol Severe coagulation conditions Inability to tolerate anticoagulation therapy Contraindication to contrast media or allergy to nitinol Active infection, including endocarditis Congenital aortic stenosis or unicuspid or bicuspid aortic valve Non-valvular aortic stenosis Hypertrophic obstructive cardiomyopathy | 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): 10.0-15.0, Children Cardiovascular Risk Factors The study was conducted in children attending 5th and 6th grade in all 20 public schools of the Municipality of Puente Alto, Santiago, Chile. All students were invited to participate in the study. Parents or their representatives signed an informed consent form and boys/girls an informed acceptance form Subjects not signing the informed consent or acceptance forms were excluded from 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): 18.0-90.0, Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Coronary artery bypass graft, and mitral/aortic valve replacement patients recovering from sternotomy procedure eligible for cardiac rehabilitation Able to provide written informed consent Male or female 18 years of age or greater Patients with any of the following Serious cardiac arrhythmias Current neurological disorders or previous Cerebral Vascular Accident with residual neurological deficit significant enough to limit exercise Enrolled on another clinical trial that involved exercise Unable to enroll for duration of study Patients who are unable to provide written consent Patients under the age of 18 or over the age of 90 | 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): 30.0-70.0, Cardiovascular Risk Factor Metabolic Syndrome Hypertension Presence of at least one of the following formerly assessed through routine medical examination dyslipidemia, defined as the presence of either: elevated total cholesterol (>5.2 mmoL/L), and/or elevated LDL-cholesterol (>3.4 mmoL/L), and/or elevated triglycerides (>1.7 mmoL/L), and/or decreased HDL-cholesterol (<1.6 mmoL/L) elevated blood pressure (systolic/diastolic ≥120/80 mmHg), or regular anti-hypertension therapy presence of allergy on any nuts presence of any chronic disease, excluding following conditions: hypertension and diabetes mellitus type 2 smoking statin therapy pregnancy and/or lactation | 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 moderate to severe or severe symptomatic mitral regurgitation Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject may not be optimally treated with approved transcatheter repair or conventional mitral valve surgery prior transcatheter mitral valve procedure with device currently implanted anatomic contraindications prohibitive mitral annular calcification left ventricular ejection fraction <30% need for emergent or urgent surgery hemodynamic instability | 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 Primary Mitral Regurgitation grade 3+ or 4+ Patients in class II to IV NYHA Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) or age < 75 years and STS score > 8 % or at least one other high-risk criterion following the MVARC definitions Isolated Mitral valve pathology If revascularization procedures are required, they must be performed more than 30 days from intervention (D0) Patients affiliate to social security Non-inclusion Life expectancy < 1 year due to non-cardiac conditions Secondary Mitral regurgitation Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months Not eligible for a MitraClip® intervention after Core Lab evaluation Before randomization (D-21) the patient no longer fulfills (inclusion and non-inclusion criteria) | 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 severe primary mitral regurgitation due to degenerative mitral valve disease previous open cardiac surgery indication for concomitant aortic valve replacement left ventricle impairment (ejection fraction < 40%) | 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 Age ≥ 18 years Patient referred for mitral valve surgery Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient committee Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse Patient 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 Age < 18 years Infective endocarditis 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 Evidence of cirrhosis or hepatic synthetic failure Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery) | 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): 18.0-85.0, Mitral Valve Regurgitation of Any Grade both genders age between 18 and 85 years old (adult, senior) sinus rhythm hHemodynamic stable mitral valve regurgitation (MVR) of any grade i.e., from mild to severe as determined by assessment of a qualifying TransThoracic Echocardiography (TTE) exam at Saint-Luc University Hospital scheduled for TransEsophageal Echocardiography (TEE) at Saint-Luc University Hospital, as part of the subject's routine standard of care subjects has functional capacity to give written informed consent pregnancy subject lacks functional capacity to give written informed consent belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures Among the120 subjects, there will be three (3) sub-groups as follows a first sub-group (A) of 50 subjects with all and none of the a second sub-group (B) of 50 subjects with additional criterion: scheduled for cardiac Magnetic Resonance (cMR), as part of the subject's routine standard of care a third sub-group (C) of 20 subjects with additional criterion: scheduled for MitraClip transcatheter mitral valve repair (MitraClip) procedure as part of the subject's routine standard of care | 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 Severe ischemic mitral valve regurgitation years of age, and able to provide informed consent Mixed mitral valve pathology Acute ischemic 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, Outcomes of Trabeculectomy With MMC Fesh trabeculectomy surgeries recurrent surgeries | 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, Aortic Stenosis Myocardial Fibrosis Left Ventricular Hypertrophy (aortic stenosis group) Age over 18 Severe aortic stenosis with planned aortic valve replacement (control group) Age over 18 Planned non-aortic valve cardiac or elective ascending aorta surgery (aortic stenosis group) Coexistent severe aortic or mitral regurgitation Coexistent mitral stenosis greater than mild in severity Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) Acute pulmonary oedema or cardiogenic shock Coexistent hypertrophic cardiomyopathy Unable to give informed consent (control group) Significant aortic valve disease (mild aortic stenosis / regurgitation or greater) Acute valvular heart disease (e.g. acute mitral regurgitation or endocarditis) | 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 Mitral Valve Disease General 1. Age ≥ 18 years 2. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) 4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated. 5. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities. 6. Able to undergo Transesophageal Echocardiography (TEE). 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. 8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital. Anatomical 9. Suitable for femoral access procedure and trans septal catheterization 10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee) Cardiovascular Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability 2. Acute myocardial infarction within the previous 30 days 3. Any prior heart valve surgery or transcatheter mitral intervention 4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days 5. Rheumatic heart disease or endocarditis within the previous 3 months 6. 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 7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization) 8. Untreated clinically significant coronary artery disease requiring revascularization 9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation 10. Aortic or pulmonic valve disease requiring surgery 11. CRT/ICD implant within 30 days Anatomical (assessed by pre-procedural imaging) 12. Left Ventricular Ejection Fraction (LVEF) <30% 13. LV end diastolic diameter > 70mm 14. Significant abnormalities of the mitral valve and sub-valvular apparatus. 15. Severe mitral annular or leaflets calcification 16. Left atrial or LV thrombus or vegetation 17. Severe right ventricular dysfunction 18. Severe tricuspid or aortic valve disease General Subject who is currently participating in an investigational study, other than this study 20. Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance 21. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications 22. Bleeding diathesis or hypercoagulable state 23. Active peptic ulcer or active gastrointestinal bleeding 24. Pulmonary artery systolic pressure >70 mmHg 25. Patients with renal insufficiency (creatinine > 2.5 mg/dL) 26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months 27. Subject with hepatic insufficiency 28. Subject has a co-morbid illness that may result in a life expectancy of less than one year 29. Active infection that requires antibiotic therapy 30. Subject is pregnant, breastfeeding or intend to become pregnant within one year | 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, Cardiomyopathy Cardiovascular Diseases Congestive Heart Failure Coronary Artery Disease Heart Disease Valvular Heart Disease Mitral Valve Disease Patients with functional mitral regurgitation (FMR) from either ischemic or non-ischemic cardiomyopathies, referred for surgical or transcatheter mitral valve annuloplasty. Suitability for mitral annuloplasty is determined by the surgeon, using some or all the described below Left ventricular end diastolic diameter is less than or equal to 70mm Systolic tenting height is less than or equal to 12mm Mitral regurgitation of moderate or greater severity, as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic echo) Cardiomyopathy of ischemic or non-ischemic origins, with or without the need for coronary revascularization Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf Any evidence of structural (chordal or leaflet) mitral lesions Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect) Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation Persistent atrial fibrillation Prior mitral valve repair Contraindication for cardiopulmonary bypass Clinical signs of cardiogenic shock at the time of randomization ST segment elevation myocardial infarction within 14 days prior to in this study Congenital heart disease (except PFO or ASD) Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac 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, Degenerative Mitral Regurgitation (MR) Due to Leaflet Prolapse Asymptomatic patients according history or an exercise test in those able to perform it if there is a doubt about the absence of symptoms Severe (grade IV) degenerative MR due to leaflet prolapse assessed by echocardiography LV ejection fraction by Simpson biplane method ≥60% and LV end-systolic diameter by TM echocardiography ≤40mm Sinus rhythm on the ECG Pulmonary artery pressure ≤50 mmHg by Doppler echocardiography High probability of mitral valve repair EuroSCORE II ≤ 3% Mitral stenosis or > mild aortic valve disease (stenosis or regurgitation) Congenital heart disease (except patent foramen ovale or atrial septal defect) Patients with cardiac prostheses Previous myocardial infarction Previous cardiac surgery Extra cardiac comorbidity with life expectancy < 5 years Recent history of psychiatric disease (including drug or alcohol abuse) Therapy with an investigational intervention at the time of screening or plan to enrol patient in additional intervention study during participation in this 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): 18.0-999.0, Gastroesophageal Reflux Males and non-pregnant females over the age of 18 years Gastro-oesophageal symptoms in accordance with Montreal criteria49 Patients who had oesophageal physiology testing at Guy's and St Thomas' NHS Foundation Trust Oesophageal manometry based on Chicago classification hour standard pH, impedance-pH and Bravo™ Minimum 6 months post ARS and follow-up at GSTT Verbal consent over the phone Patients less than 18 years of age Pregnancy at the time of interview Patients unable to comprehend or answer the questionnaires Oesophageal physiology tests performed in other centres | 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): 18.0-35.0, Failed Induction Cervical Dystocia Age (18-35) years. 2. Singleton pregnancy. 3. (37-42) weeks gestation. 4. Living fetus. 5. Cephalic presentation. 6. Absence of active labour. 7. No contraindication to vaginal delivery. 8. Average amount of clear liquor. 9. No history of uterine scar (myomectomy or previous C.S( Malpresentation. 2. Major fetal congenital anomalies as hydrocephalous & dead fetus. 3. Patient received any pre induction ripping methods for example: (Acetic Acid-Prostaglandins). 4. Any medical history contraindicating vaginal delivery. 5. Assessment meconium staining to liquor or any evidence of chorioamnionitis. 6. Previous uterine surgery. 7. Multiple gestations. 8. Women with allergy to prostaglandins | 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 Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart Heart Valve Diseases Functional Mitral Regurgitation Degenerative Mitral Valve Disease Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC) NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory) The local site heart team determines that the subject has been adequately treated per applicable standards Not a member of a vulnerable population Mitral valvular vegetation or mass Left ventricular ejection fraction < 25% Left ventricular end diastolic diameter > 7.0 cm Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material Aortic valve disease requiring surgery or transcatheter intervention Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention Any planned surgical / interventional procedure within 60 day prior to or following subject randomization Subject undergoing hemodialysis due to chronic renal failure Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 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): 0.0-999.0, Aortopathies Thoracic Aortic Aneurysm Aortic Valve Disease Thoracic Aortic Disease Thoracic Aortic Dissection Thoracic Aortic Rupture Ascending Aortic Disease Descending Aortic Disease Ascending Aortic Aneurysm Descending Aortic Aneurysm Marfan Syndrome Loeys-Dietz Syndrome Ehlers-Danlos Syndrome Shprintzen-Goldberg Syndrome Turner Syndrome PHACE Syndrome Autosomal Recessive Cutis Laxa Congenital Contractural Arachnodactyly Arterial Tortuosity Syndrome Open to external enrollment Subjects with a genetic diagnosis of Marfan Syndrome (MDS), Loeys-Dietz Syndrome (LDS), or Vascular Ehlers-Danlos Syndrome (EDS); (Positive genetic testing or a previous cardiac study required to be eligible) Family members of eligible subjects (Only family members of subjects with syndromic diagnoses are eligible for external enrollment at this time) Closed to external enrollment Subjects with aortic disease including TAA* or dissection, aortic tortuosity, or aortic hypoplasia/stenosis (based on any cardiac imaging modality including echocardiography, CT, MRI, or angiography) Subjects with aortic valve disease (bicuspid, unicuspid, or tricuspid disease) Control subjects having tissue removed during a surgical procedure (e.g. coronary artery bypass graft surgery (CABG), cardiac transplant, etc.) • Inability or unwillingness to provide consent (assent when indicated) | 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): 20.0-85.0, Atrial Functional Mitral Regurgitation Heart Failure NYHA(New York Heart Association) Class III and, Functional Mitral Regurgitation 3+ (Moderate/Severe) or 4+ (Severe) in spite of optimal medical treatment. (For optimal medical treatments, ①ACE inhibitor or angiotensin receptor blocker ②β-blocker ③ aldosterone antagonists should be given for at least 3 months unless the subject has contraindication for each drug) and, Chronic Atrial Fibrillation in electrocardiography (Persistent AF or Permanent AF) Primary Mitral Regurgitation LV ejection fraction lower than 30% Pulmonary arterial pressure ≥ 60mmHg End-diastolic Left ventricular dimension ≥ 70mm Subjects with functional MR who need CABG or AVR performed Pre-existing stent in a coronary artery that is deemed to be in direct contact with the path of mitral loop cerclage along coronary sinus Subjects who have functional MR caused by aortic valve disease Subjects who have uncontrollable hyperthyroidism Subjects who have severe TR due to primary valve leaflet disease Anomaly of Coronary Sinus | 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 Insufficiency Left Ventricular Systolic Dysfunction Mitral Valve Prolapse functional mitral valve insufficiency with reduced mobility of leaflets during systole (type IIIb) effective regurgitation orifice area > 20 mm2 / regurgitant volume > 30 ml/beat left ventricular ejection fraction <= 50% and /or left ventricular end-diastolic diameter >= 60 mm tenting of the proximal and / or anterior mitral leaflets prolaps of leaflets (type II mitral regurgitation) combination intervention with aortic valve repair or replacement re-operation at mitral valve | 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): 21.0-999.0, Heart Failure Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days All subjects must be 21 years of age or older on the day of screening Subjects who are wearing the wearable cardioverter defibrillator (WCD) Subjects not expected to survive one year from enrollment from non-cardiac disease Subjects with skin allergy or sensitivity to medical adhesives Subjects anticipated to start dialysis within 90 days Subjects currently implanted with an S-ICD system Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation Subjects who are unable to participate in all follow up visits Subjects participating in any other research at time of enrollment Subjects currently implanted with an LVAD | 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 Mitral Valve Regurgitation Refer to MitraClip IFU Refer to MitraClip IFU | 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, Mitral Valve Prolapse All patients that surgical for Neochord implantation with transapical mini-thoracotomy are prolapsus or chordae rupture in posterior, anterior areas or in both leaflets were included are active endocarditis, functional or ischemic mitral insufficiency (MI), excessive calcific valves, leaflet perforation, anemic dilatation and severe left ventricular dysfunction | 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): 21.0-999.0, Mitral Regurgitation Patients moderate to severe, symptomatic functional (ischemic or dilated cardiomyopathies) mitral regurgitation or mitral regurgitation caused by dilation of the mitral annulus who qualify for mitral valve repair with cardiopulmonary bypass Mitral regurgitation must meet the following The primary regurgitant jet is central, originating from mal coaptation of anterior and posterior leaflets of the mitral valve If a secondary jet is present, the jet must be considered clinically insignificant Women of child-bearing potential have a negative pregnancy test Evidence of severe mitral annular and leaflet calcification Patient is hemodynamically unstable Patient has hypertrophic cardiomyopathy and has systolic anterior motion of the leaflets Patient requires emergency surgery Patient has echocardiographic evidence of endocarditis or rheumatic heart disease Transesophageal Echocardiogram (TEE) is contraindicated or cannot be performed intraoperatively for any reason Patient has known chronic, dialysis-dependent renal failure History of stroke, transient ischemic attack (TIA) or reversible ischemic neurological disease within the last three (3) months History of gastrointestinal bleeding within the last three (3) months History of hypersensitivity or allergy to aspirin | 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): 12.0-999.0, Diet Modification Substance Use Disorders Diabetes Mellitus Risk Cardiovascular Risk Factor Lifestyle Risk Reduction Parenting Youth: ages 12-14 Youth: Enrolled in 6th,7th, or 8th grade at the time of recruitment from the American Dream Academy (ADA) programs Adults: Age 18 or older Adults: Parent/caregiver/guardian of an eligible youth 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): 18.0-90.0, Mitral Regurgitation Patients who are eligible for Mitraclip device according to current national and international guidelines (and their future revisions) and per investigator evaluation Patients who are willing and capable of providing informed consent, participating in all Follow-ups associated with this clinical investigation at an approved clinical investigational center; More specifically patients are in line with the indications for use detailed in the IFU in particular, patients have to meet the following inclusions 1. Symptomatic severe (4+) MR, or 3+ MR and NYHA > II. 2. Mitral valve anatomy should be suitable for MitraClip. 3. Signed (by subject or legal representative) and dated approved subject informed consent form prior to any study related data collection Valve anatomy is unsuitable for MitraClip therapy as per the indication in the Mitraclip IFU Currently participating in the study of an investigational drug or device The subject is unable or not willing to complete follow-up visits and examination for the duration of the study | 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, Gestational Diabetes Women with a history of GDM in previous pregnancies Age ≥ 18 years Singleton pregnancy ≤ 16 weeks gestation • Women unable or unwilling to give consent Pre-gestational diabetes or use of anti-diabetic medication in the first visit Significant chronic medical conditions (cardiovascular, liver or kidney disease) Women participating in other medical trial Women who have undergone bariatric surgery Women with milk allergy/intolerance Women unable to speak/understand English | 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, Obesity Metabolic Syndrome Male or female patients with schizophrenia or mood disorders, followed at Taipei City Psychiatric Center will be the targeted study population. The subjects should fulfill the following 1. Age between 20 to 65 years. 2. Currently taking antipsychotics or mood stabilizers. 3. BMI should be ≥ 27 kg/m2. 4. Good adherence to medications as recorded by chart. 5. Competent to understand the informed consent and have motivation to decrease their body weight Unstable psychiatric symptoms or physical condition that may interfere the adherence of medication. 2. Medical conditions such as endocrine disease, heart disease, allergy or immunology disease, or impaired liver function (high aminotransferases, alanine, aspartate >80 IU/L or serum creatinine >2.5 mg/dl. 3. Pregnant or lactating women. 4. Childbirth within 6 months. 5. Management for weight control within 3 months. 6. Any other conditions deemed unsuitable for trial as evaluated by the physician-in-charge | 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, Right Ventricular Dysfunction Rheumatic Heart Disease All ages will be accepted Isolated mitral valve lesion either stenosis or regurge Good LV function (EF <45%) Any degree of tricuspid valve regurge Concomitant Aortic valve lesion needs replacement Poor LV function (Low EF> 45%) Other causes of pulmonary hypertension i.e.: (Chronic obstructive or restrictive pulmonary disease, connective tissue disease and chronic thromboembolism) Emergency and Redo operations | 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, Heart Failure Cardiomyopathy, Dilated Study patient is at least 18-years old Severity of FMR: ≥ Moderate (i.e., ≥2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2) Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment LV Ejection Fraction: ≥20 to ≤40% Symptom Status: NYHA II-IV (i.e., ambulatory) Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall CRT and/or ICD when indicated by guidelines Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets) Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months Prior surgical, transcatheter, or percutaneous mitral valve replacement Untreated clinically significant coronary artery disease (CAD) requiring revascularization Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support Any planned cardiac surgery or interventions within the next 6 months (including right heart procedures) NYHA class IV (i.e., non-ambulatory) Fixed pulmonary artery systolic pressure >70 mmHg Severe tricuspid regurgitation History of stroke within the prior 3 months or any prior stroke with Modified Rankin Scale ≥ 4 disability | 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, Anastomotic Leak Colorectal Surgery Patients submitted to laparoscopic/robotic/open/converted ileo-colo-rectal resection with anastomosis (both intra and/or extra-corporeal), including planned Hartmann's reversals. 2. American Society of Anesthesiologists' (ASA) class I, II or III 3. Elective surgery 4. Patients' written acceptance to be included in the study American Society of Anesthesiologists' (ASA) class IV-V 2. Patients with stoma before or at operation 3. Simple stoma closure 4. Transanal procedure 5. Pregnancy 6. Ongoing infection prior to surgery 7. Hyperthermic intraperitoneal chemotherapy for carcinomatosis | 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, Diabetic Retinopathy Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery Patients who need cataract surgery without any intravitreal injections Absence of any ocular disease other than diabetes mellitus Cataract density allowing good visualization of the fundus by OCT angiography Patients with uneventful cataract surgery with phacoemulsification Patients who fail to comply with the follow-up schedule Very dense cataract not allowing good visualization of the fundus by OCT angiography Patients with complicated cataract surgery with phacoemulsification Patients who need cataract surgery with any intravitreal injection | 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): 5.0-19.0, Marfan Syndrome 19 years of age (patient) seen in at least 2 prior clinic visits Marfan syndrome by revised Ghent presence of parent at home prior aortic surgery known cardiomyopathy known arrhythmia aortic root > 4.5 cm in prior clinic visit pregnancy | 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 Regurgitation Patient has undergone percutaneous mitral valve repair with MitraClip Clip Delivery System in Canada 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): 18.0-80.0, Mitral Valve Prolapse Mitral Regurgitation Mitral Valve Disease Patients undergo mitral valve repair with either surgery of MitraClip techniques Over 18 years old Unable to place TEE probe Refuse consent | 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 Subject has documented severe aortic stenosis defined as initial AVA ≤1.0 cm2 (or AVA index ≤0.6 cm2/m2) AND a mean pressure gradient ≥40 mm Hg OR maximal aortic valve velocity ≥4.0 m/s OR Doppler velocity index ≤0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended)c; the subject may be enrolled if echocardiographic are met with this augmentation. (IC1) A subject in the Bicuspid Aortic Valve Nested Registry cohort must have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab with hemodynamic parameters that meet the in IC1 Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) Subject has symptomatic aortic valve stenosis per IC1 definition above with NYHA Functional Class ≥ II Heart team (which must an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject is at intermediate risk of operative mortality (≥3% and <8% at 30 days based on the Society of Thoracic Surgeons [STS] risk score and other clinical comorbidities unmeasured by the risk calculator) and TAVR is appropriate. Note: Risk of operative mortality must be assessed via an in-person evaluation by a center cardiac surgeon and must be confirmed by the CRC (which must an experienced cardiac surgeon) Heart team agrees that the subject is likely to benefit from valve replacement. IC7. Subject (or legal representative) has been informed of the study requirements and the treatment procedures, and provides written informed consent Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow-up visits Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy Subject has a unicuspid or bicuspid aortic valve (not applicable to subjects in the Bicuspid Nested Registry cohort) Subjects in the Bicuspid Nested Registry cohort will have a documented Sievers Type 0 or Sievers Type 1 bicuspid aortic valve based on CT assessment and confirmed by the CT core lab. Subjects are not eligible for in the Bicuspid Nested Registry cohort if the maximum diameter of the ascending aorta is >45 mm or if the subject has another indication for aortic root replacement. Subjects with a Sievers Type 2 bicuspid valve are not eligible for enrollment in any study cohort Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation ≥ twice normal in the presence of CK-MB elevation and/or troponin elevation) Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment Subject is on renal replacement therapy or has GFR <20 (based on hospital preferred method). See AEC1 below if subject is in the CT Imaging Substudy Subject has a pre-existing prosthetic aortic or mitral valve Subject has severe (4+) aortic, tricuspid, or mitral regurgitation Subject has moderate to severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or Dc) Subject has a need for emergency surgery for any reason Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis | 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): 18.0-45.0, Infertility Patients initiating an autologous IVF cycle 2. Patient age 18-45; partner age 18-60 3. Partner planning to provide fresh semen sample on day of oocyte retrieval 4. Patients planning to undergo preimplantation genetic screening (PGS) of embryos with single embryo transfer (SET) > 1 prior failed IVF cycle 2. Third party reproduction 3. Planning to bank embryos 4. Partner using cryo sperm or surgical sperm on day of retrieval 5. Male or female partner antibiotic use within 1 month of IVF cycle start 6. Mullerian anomalies, excluding arcuate uterus 7. Submucosal fibroids 8. History of uterine surgery, excluding polypectomy, D&C, and Cesarean section 9. Communicating hydrosalpinx without plans for surgical correction prior to embryo transfer | 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): 18.0-44.0, Gestational Diabetes Study group women between 24 weeks' gestation who were diagnosed with gestational diabetes mellitus or known with type I or type II diabetes mellitus. Control group women between 24 weeks' gestation who do not have diabetes women who did not complete a glucose challenge test, smoking, underlying cardiac or respiratory illness, fetal growth restriction, medicated hypertension disorder of pregnancy, multiple pregnancy, use of steroids for lung maturation in the current pregnancy and known major congenital anomalies | 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 Mitral Valve Disease Mitral Valve Failure Mitral Disease Valve Heart Disease Valve Disease, Heart Has severe mitral regurgitation New York Heart Association (NYHA) Class II, III, IVa or heart failure High risk for cardiovascular surgery Excessive calcification or thickening of mitral valve annulus Severe mitral stenosis, fused commissures, valvular vegetation or mass Left ventricular end diastolic dimension > 7cm Left ventricular outflow tract obstruction Severe right ventricular dysfunction Stroke within 90 days; transient ischemic attack or myocardial infarction within 30 days of the index 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): 0.0-999.0, Valvular Heart Disease (Aortic and Mitral Valves) Patients with clinically diagnosed valvular heart disease and confirmed by echocardiography Patients with known contraindication to MRI including the presence of paramagnetic Surgical clips, or pacemakers Severely ill patients Claustrophobic or restless subjects Patients with arrhythmia | 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, Degenerative Mitral Valve Disease Isolated type II mitral valve insufficiency by A. Carpentier 2. Mitral regurgitation degree >2 3. Age >18 years 4. Signed informed consent to participate in the study Any other cardiac surgeries 2. Age <18 years 3. Multiple organ failure 4. ReDo procedure 5. Persistent atrial fibrillation 6. Acute infective endocarditis 7. Refusal to sign informed consent | 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, Myocardial Function of the Stenosis Aortic Valve Before and Beyond Valve Replacement major patient freely accepting to participate in the study non-opposition signed aortic surface <1cm² or <0.6cm² / m² of indication surgical restraint oriented to short interventional management surgical term LVEF Left ventricular ejection fraction> 50% In the subgroup "MRI-fibrosis", absence of indication for performing MRI patient under guardianship, curatorship or safeguard of justice minor patient pregnant woman patient with significant polyvalvulopathy for which it is from the start programmed more than aortic valve replacement patient with severe coronary artery disease requiring revascularization allergy to the contrast product | 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, Degenerative Mitral Valve Disease Mitral Regurgitation Mitral Insufficiency Functional Mitral Regurgitation Eighteen (18) years of age or older Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only) Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only) Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both and MitraClip Mitral regurgitation (3+ to 4+) by echo Suitable valve and regurgitant jet morphology Elevated BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only) Patient in whom a TEE is contraindicated or screening TEE is unsuccessful Mitral valve anatomy which may preclude proper or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure) Clinically significant, untreated coronary artery disease Recent stroke Other severe valve disorders requiring intervention Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair) Active rheumatic heart disease or rheumatic etiology for MR Severe aortic stenosis or 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): 18.0-999.0, Mitral Regurgitation General 2. NYHA functional II, III or ambulatory IV 3. Severe mitral regurgitation (MR grade 3-4+) with pronounced secondary MR etiology 4. Subject is on optimal guideline-directed medical therapy for heart failure for at least 30 days or CRT if indicated. 5. Elevated risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) based on STS/Euro Score II (per MVARC Part 1), frailty and co-morbidities. 6. Able to undergo Transesophageal Echocardiography (TEE). 7. Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed. 8. The subject commits to return for the scheduled post-operative follow-up visits at the hospital. Anatomical 9. Suitable for femoral access procedure and trans septal catheterization 10. Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve (as assessed by the independent Screening Committee) Cardiovascular Prior stroke or TIA within 3 months or Modified Rankin Scale ≥4 disability 2. Acute myocardial infarction within the previous 30 days 3. Any prior heart valve surgery or transcatheter mitral intervention 4. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days 5. Rheumatic heart disease or endocarditis within the previous 3 months 6. 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 7. Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization) 8. Untreated clinically significant coronary artery disease requiring revascularization 9. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation 10. Aortic or pulmonic valve disease requiring surgery 11. CRT/ICD implant within 30 days Anatomical (assessed by pre-procedural imaging) 12. Left Ventricular Ejection Fraction (LVEF) <30% 13. LV end diastolic diameter > 70mm 14. Significant abnormalities of the mitral valve and sub-valvular apparatus. 15. Severe mitral annular or leaflets calcification 16. Left atrial or LV thrombus or vegetation 17. Severe right ventricular dysfunction 18. Severe tricuspid or aortic valve disease General Subject who is currently participating in an investigational study, other than this study 20. Hemodynamic instability defined as systolic pressure < 90mmHg or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device, or any mechanical heart assistance 21. Subject has contrast agent hypersensitivity that cannot be adequately pre-medicated, has an allergy to Nitinol alloys (nickel and titanium), or has intolerance to antiplatelet, anticoagulant, or thrombolytic medications 22. Bleeding diathesis or hypercoagulable state 23. Active peptic ulcer or active gastrointestinal bleeding 24. Pulmonary artery systolic pressure >70 mmHg 25. Patients with renal insufficiency (creatinine > 2.5 mg/dL) 26. Need for emergent or urgent surgery for any reason or any planned cardiac Surgery within the next 12 months 27. Subject with hepatic insufficiency 28. Subject has a co-morbid illness that may result in a life expectancy of less than one year 29. Active infection that requires antibiotic therapy 30. Subject is pregnant, breastfeeding or intend to become pregnant within one year | 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, Cystocele Vaginal Vault Prolapse Rectocele Enterocele Symptomatic prolapse stage >1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System Negative Pap-smear Asymptomatic prolapse prolapse stage <=1 prolapse of uterus presence of any type of genital infections (i.e herpes, vaginitis etc) vaginal bleeding underlying pathologies that could interfere in patients compliance (i.e psychiatric) | 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): 21.0-99.0, Dry Eye Patients with dry eye symptoms, who cannot be satisfactorily managed by currently available dry eye medication 2. TBUT ≤10s 3. Presence of corneal fluorescein staining 4. Visual acuity affected by poor tear film quality 5. No contraindication for blood extraction/ plasmapheresis 6. Age between 21 to 99 years old 7. Skin lesions The skin at the site of venepuncture in the antecubital area should be free of lesions. Donors with boils, open wounds, chronic eczema or any severe skin infection must be rejected Active ocular infection. 2. Any other specified reason as determined by clinical investigator 3. Severe cardiovascular disease 4. Severe respiratory disease 5. Uncontrolled epilepsy 6. Abnormal bleeding conditions 7. Pregnancy 8. Infectious diseases Patients who are known or diagnosed to have HIV, Hepatitis B or Hepatitis C carriers should not be accepted for donation Patients who have risk factors for infectious diseases should not be accepted for donation. 9. Patients who have been or are being treated for bacteraemia, or have a significant bacterial infection that can be associated with bacteraemia. 10. Unable to come for follow up at the required frequencies and duration. This includes non-Singapore residents who are patients of the dry eye clinic. 11. In order to avoid serious infections, especially corneal keratitis, we will not patients with high risks for infection in this study, such as those patients with a persistent epithelial defect, wearing of contact lenses, previous ocular surgery such as penetrating keratoplasty or any other ocular surgery. 12. Patients with persistent epithelial defect that requires bandage contact lens | 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): 5.0-15.0, Metabolic Syndrome Cancer survivors Treatment with chemotherapy and/or radiation therapy for a primary ALL/NHL diagnosed prior to age 17 years ≤ 15 years of age at the time of enrollment No cytostatic drugs uptake during the study Diagnosis of diabetes mellitus types 1 or 2 types before antitumor therapy Active oncological disease History of allogeneic hematopoietic cell transplant The renouncement of participation from the patient or legally authorized representative | 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): 18.0-84.0, Mitral Regurgitation Age ≥ 18 years Symptomatic (Stage D) severe MR confirmed by the echo core lab Cardiac Index > 2.0 Left Ventricular Ejection Fraction (LVEF) is ≥ 30% (within 90 days prior to subject enrollment based upon TTE) New York Heart Association (NYHA) Functional Class II, III or ambulatory IVa Prior treatment with Guideline Directed Medical Therapy (GDMT) for heart failure for at least 30 days prior to index procedure Patient deemed a high surgical risk per MVARC definition by the site's Heart Team (as a minimum, one MV cardiac surgeon and one interventional cardiologist, and a cardiac imaging expert) MR etiology that is exclusively Primary (degenerative) Echocardiographic or angiographic evidence of severe mitral annular calcification Echocardiographic evidence of EROA < 0.3cm2 Untreated clinically significant coronary artery disease requiring revascularization Hypertrophic/restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than other than cardiomyopathy of either ischemic or non-ischemic etiology Hypotension (systolic pressure < 90 mm Hg)/Cardiogenic shock or other hemodynamic instability requiring the need for inotropic Fixed pulmonary artery systolic pressure > 2/3 of systemic systolic blood pressure LVEDD >75 mm Severe tricuspid regurgitation or evidence of severe right ventricular dysfunction Anatomy deemed not suitable for the Cardiovalve | 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): 18.0-85.0, Gastroesophageal Reflux Disease Patients submitted to primary minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia Age > 18 years Patients already submitted to minimally invasive surgery for gastroesophageal reflux diseases or hiatus hernia for recurrence of the disease Patients submitted to open surgery for gastroesophageal reflux diseases or hiatus hernia Patients affected by other esophageal diseases Age < 18 years | 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): 15.0-50.0, Hypertension, Pregnancy-Induced Hypertension, Essential Hypertension Hypertension; Pre-Eclampsia Hypertension in Pregnancy High risk pregnancy At 12-16 weeks of gestation Aged between 15 to 50 years Living in Matlab bangladesh Have congenital malformation/anomaly in current pregnancy Current pregnancy have chromosomal abnormality e.g. Down syndrome Have chronic debilitating illness Mother is a known case of psychosis Who do not have electricity at their house Do not have smart phone at their house | 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): 18.0-71.0, Revisions After MGB/OAGB Morbidities Morality They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight. 2. All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss. 3. The person has been receiving or will receive intensive management in a tier 3 service. 4. The person is generally fit for anaesthesia and surgery. 5. The person commits to the need for long-term follow-up. 6. Age 18-71 years - Less than 18 or more than 71 years of age 2. Not fit for bariatric surgery 3. Psychiatric illness - | 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, Long QT Syndrome Hypoglycemia Healthy men and women Age ≥20 and ≤40 years BMI ≥18,5 and ≤27,5 Chronic diseases (cardiac, metabolic, liver) including a family history of congenital Long QT syndrome QTc values >440 ms (men) and >450 ms (women) Clinical important and/or symptomatic bradycardia Regular medication (contraceptive pills allowed) Pregnancy and breastfeeding | 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): 18.0-75.0, Advanced Solid Tumors Males and/or females age from 18 to 75; 2. Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator; 3. In the dose escalation portion, both measurable and non-measurable tumor lesions were acceptable according to criteria;There was at least one measurable tumor lesion in the dose expansion portion; 4. Eastern Cooperative Oncology Group performance status of 0 to 1; 5. Life expectancy of at least 3 months; 6. Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L; Platelet count(PLT)≥100×109/L; Hemoglobin(Hb)≥90 g/L; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤2.5×ULN; Aspartate aminotransferase(AST)≤2.5×ULN; Creatinine(Cr)≤1.5×ULN; Creatinine clearance ≥50ml/min;Left Ventricular Ejection Fractions(LVEF)≥50%; QTcF<450 ms; 7. The washout period from the last time accepting any anti-tumor treatment (including radiation therapy, chemotherapy, hormone therapy, surgery, or molecular targeted therapy) to participating in this test should be 3 weeks or more.The washout period of oral fluorouracil should be 2 weeks or more, and that of mitomycin and nitrosocarbamide should be 6 weeks or more; 8. Fertile male and female must agree to use medically approved contraceptives during the study and within 6 months after the last dose of the study; 9. Female who is capable of conceiving:Blood pregnancy tests should be negative 7 days before the first dose; Patients cannot breastfeed, if the subject has stopped breastfeeding at the time of study entry, the cessation of breastfeeding must be from the day of first dose to more than 30 days after the last dose; 10. The last time participate in an investigational drug study should be more than one month prior to the study entry; 11. According to the judgment of the investigator, the subject has high compliance and is willing to complete the experiment and comply with the protocol; 12. Voluntary participation in this clinical trial, understanding of the study procedures and the ability to sign informed consent forms (ICFs) There are third interstitial effusions (such as massive pleural effusion and ascites) which can not be controlled by drainage or other methods; 2. Within 3 months before the first dose, grade 3 or grade 4 gastrointestinal bleeding or varicose bleeding and requiring blood transfusion or endoscopic or surgical intervention has happened; 3. Medical history of difficulty in swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product; 4. subjects with a definitely history of neurological or psychiatric disorders; 5. Known infection with human immunodeficiency virus (HIV), hepatitis B virus(HBV), or hepatitis C virus (HCV); 6. History of immunodeficiency, including HIV positive test, other acquired or congenital immunodeficiency disorders, organ transplantation or allogeneic bone marrow transplantation; 7. Exists moderate or severe heart disease: (1) Within 6 months before the first dose,myocardial infarction, angina, grade III/IV congestive heart failure, pericardial effusion, uncontrollable severe hypertension (up to 150/90 mmHg or less) (2) ECG abnormalities with clinical significance: symptomatic or persistent atrial or ventricular arrhythmias, degree II or III atrioventricular block, bundle branch block, ventricular hypertrophy; (3) The echocardiogram shows significant abnormalities: For example, moderate or severe heart valve function defects are assessed according to the normal lower limit of the institution;Patients with minor or mild valve regurgitation (tricuspid, pulmonary, mitral, or aortic) can be included in this study (4) Laboratory examination shows brain natriuretic peptide or troponin T levels increases (5) Various factors that may increase the risk of QTcF prolonging or arrhythmia events. For example, hypokalemia, congenital long QT syndrome, may prolong the QT interval of various combined drugs, etc. (6) Predisposition factors cause the development of ascending aorta or aortic arch aneurysm: For example, marfan syndrome, CT records of the history of cardiac vascular injury; (7) History of heart or aortic surgery. 8. Patients with central nervous system metastasis; 9. At the beginning of the study, the unrecovered toxicity of the previous treatment exceeded CTCAE5.0 grade 1(except for hair loss); 10. Previously treated with TGF-β inhibitors; 11. According to the judgement of the researcher,there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.). 12. subjects, in the opinion of the the Investigator, who are unsuitable to participate in the study for any other reason | 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 Genetic Disease Patients of any age with typical mitral valve prolapse relatives examined during familial screening Refusal of the patient | 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, Mitral Valve Replacement Transfusion Reaction Blood Transfusion Complication Patients undergoing "mitral valve replacement" surgery; 2. Age 18-75 years old; 3. 48h biochemical indicators before surgery, blood general indicators, coagulation indicators are complete Lack of necessary tests and patient test information is not detailed, blood transfusion information is not detailed; 2. The blood transfusion information is not detailed in the same period as other cardiac operations (such as aortic valve surgery, coronary artery bypass grafting, etc.), but the tricuspid valvuloplasty is not ruled out at the same time; 3. Heart surgery or emergency surgery again | 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 Regurgitation Patients must meet ALL the following : 1. with primary or secondary mitral regurgitation recorded by TTE and confirmed during TEE where surgery for mitral valve repair is required with indications consistent with AHA/ACC and ESC/EACTS guidelines : 1. primary (degenerative) : severe MR grade parameters (R Vol and EROA measured by PISA methods) EROA regurgitant >60 ml and Vena contracta width > 7mm and Regurgitant fraction >50% 2. Secondary (functional) : severe MR (EROA ≥30 mm²; R Vol > 30ml) may differ from the primary MR and are based on the prognostic value of these thresholds to predict the poor outcome, or for patients undergoing CABG 2. with LVEF ≥ 30% 3. in satisfactory condition, based on the physical examination and investigator's experience, with a life expectancy above one year after the intervention 4. with or without concomitant procedures as: CABG, other valve repair/replacement, pacemaker implantation, of left appendage (with device or surgically) and Maze (or PVI) procedure 5. willing to sign the informed consent; 6. able and willing to comply with all clinical investigation requirements, including the required study follow-up visits Patients will be excluded if ANY of the following conditions are present: 1. of age < 21 years; 2. with echocardiographic measurements predicting SAM 1. LVEDD < 45 mm 2. C-Sd < 25mm (distance from the septum to the mitral valve coaptation point) 3. Basal-IVDd > 15 mm 4. aorto-mitral angle < 120° 5. pre-repair posterior leaflet height > 15 mm 3. with cardiogenic shock; 4. with active endocarditis (or having had active endocarditis in the last three months); 5. with active myocarditis; 6. with heavily calcified mitral annulus; 7. with mitral stenosis; 8. unable to take anticoagulation medications; 9. with a known untreatable allergy to contrast media or nickel; 10. with a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy shorter than 1 year, or for whom the implant of the device produces an unacceptable increase of risk; 11. with contraindication to transoesophageal echocardiography; 12. with contraindication to cardiopulmonary bypass; 13. who are pregnant or breast-feeding women; 14. involved in any other clinical investigation for drugs or devices; 15. unable to understand and sign the ICF in absence of legal protection; 16. unable to read and write | 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): 1.0-99.0, Malaria FOR 1,2,3: All of the following must be fulfilled for a volunteer to participate in this trial: 1. Meets age requirements for Arm currently being enrolled. 2. Available for the duration of the trial. 3. Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. In good general health and without clinically significant medical history in the opinion of the investigator. 6. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 0 and until 1 month after the last vaccination A reliable method of birth control includes one of the following: 1. Confirmed pharmacologic contraceptives (parenteral) delivery; 2. Intrauterine or implantable device to required pregnancy prevention includes the following: 1. Postmenopausal state: defined as no menses for 12 months without an alternative medical cause 2. Surgical sterilization 3. Unmarried AND not sexually active AND menstruating OR not menstruating females 12-17 years of age 4. NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become >=18 years of age, married, or sexually active), the female will be required to start reliable contraception 7. Willing to have blood samples stored for future research. FOR GROUP 4: All of the following must be fulfilled for a volunteer to participate in this trial: 1. Meets age requirements for Arm currently being enrolled. 2. Available for the duration of the trial. 3. Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages. 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 5. In good general health and without clinically significant medical history in the opinion of the investigator. 6. Willing to have blood samples stored for future research. for Groups 1, 2, 3, (Year 2) All of the following must be fulfilled for a volunteer to continue to participate in this trial: 1. Previously enrolled in the study and has received at least 1 vaccination. 2. Available for the duration of the trial. 3. In good general health and without clinically significant medical history in the opinion of the investigator. 4. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to scheduled vaccine dose #4 and until 1 month after the 4th vaccination. -A reliable method of birth control includes one of the following: 1. Confirmed pharmacologic contraceptives (parenteral) delivery; 2. Intrauterine or implantable device to required pregnancy prevention includes the following: 1. Postmenopausal state: defined as no menses for 12 months without an alternative medical cause 2. Surgical sterilization 3. Unmarried AND not sexually active AND menstruatingOR not menstruating females 12-17 years of age 4. NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become greater than or equal to 18 years of age, married, or sexually active), the female will be required to start reliable contraception 5. Willing to have blood samples stored for future research. for Group 4 (Year 2): All of the following must be fulfilled for a volunteer to continue to participate in this trial: 1. Previously enrolled in the study 2. Available for the duration of the trial. 3. In good general health and without clinically significant medical history in the opinion of the investigator. 4. Willing to have blood samples stored for future research FOR 1, 2, 3: An individual will be excluded from participating in this trial if any one of the following is fulfilled: 1. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (beta-hCG) test (if female). NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing 2. Menstruating females 11 years of age and younger. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group.) 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol at a level appropriate for the subject s age. 4. Hemoglobin, white blood cell (WBC), absolute neutrophil count, or platelet levels outside the local laboratory defined limits of normal. (Subjects may be included at the investigator s discretion for not clinically significant values outside of normal range and <= Grade 2.) 5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory defined upper limit of normal. (Subjects may be included at the investigator s discretion for not clinically significant values outside of normal range and <= Grade 2.) 6. Infected with HIV 7. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis. 8. Clinically significant prolonged QTc (>450 milliseconds) on screening EKG 9. History of receiving any investigational product within the past 30 days. 10. Current or planned participation in an investigational vaccine study until the last required protocol visit. 11. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 12. History of a severe allergic reaction or anaphylaxis. 13. Known Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia Immunodeficiency syndrome Seizure disorder (exception: history of simple febrile seizures) Asplenia or functional asplenia Use of chronic (>=14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone >10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0 Allergy to latex or neomycin Adverse reaction to hepatitis A and/or typhoid and/or meningococcal vaccine in the past Adverse reaction to artemether/lumefantrine in the past 14. Receipt of: -Live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks to enrollment | 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, Tricuspid Regurgitation Age > 18 years 2. Indication left-side valve surgery Unwillingness to give informed consent and to enter a regular follow-up program. 2. Prior surgical or percutaneous mitral valve intervention 3. Contraindication to cardiopulmonary bypass (CPB) 4. Clinical signs of cardiogenic shock at the time of randomization | 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 Age ≥ 18 years NYHA functional II, III or ambulatory IV Severe mitral regurgitation (MR grade 3-4+) High risk for conventional open mitral valve repair or replacement surgery in the consideration of the site Heart Team (including a cardiac surgeon, a cardiologist and imaging specialist as a minimum) Able to undergo Transesophageal Echocardiography (TEE) Subject understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed The subject commits to return for the scheduled post-operative follow-up visits at the hospital Suitable for femoral access procedure and transseptal catheterization Native mitral valve geometry and size and LV outflow tract characteristics compatible with the Cardiovalve Prior stroke or TIA within 3 months Acute myocardial infarction within the previous 30 days Any prior heart valve surgery or transcatheter mitral intervention Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days Rheumatic heart disease or endocarditis within the previous 3 months 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 Existence of inferior vena cava filter or atrial septal device (contraindicating femoral access and transseptal catheterization) Untreated clinically significant coronary artery disease requiring revascularization Tricuspid valve disease requiring surgery or severe tricuspid regurgitation Aortic valve disease requiring surgery Anatomical | 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 Insufficiency Any patient with primary mitral insufficiency by prolapse (any grade) diagnosed by Trans-Thoracic Echocardiography (TTE) From November 2010 to April 2019 (retrospective cohort) From May 2019 to May 2024 (prospective cohort) No previous surgery of the mitral valve before the first ultrasound Adults Patient who has been informed and not opposed to the use of his or her medical record data Secondary MI Primary MI without valve prolapse Active endocarditis Patient's refusal to participate in the study Patient under guardianship or curatorship | 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, Severe Mitral Regurgitation Preserved Ventricular Ejection Fraction Stage 3 or 4, primary and chronic mitral regurgitation, going for a planned surgery, with pre-operative left ventricular ejection fraction > 60% and left ventricular end-systolic dimension < 45mm Able to consent With a National Social Security number | 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, Acute Ischaemic Stroke Patients aged 18 and older at onset of an acute ischaemic stroke Availability of at least one pre-therapeutic MRI performed in our centre within 12 h of stroke onset, including a post-contrast 3D TSE T1-weighted sequence Patients with posterior fossa strokes Patients with known intracranial vasculitis or MoyaMoya disease Presence of severe MR imaging artefacts preventing correct interpretation | 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, Mitral Regurgitation 75 years Asymptomatic patients. "Asymptomatic" is defined as absence of subjective limitations of exercise capacity or complaints expressed by the patient and confirmed by the treating cardiologist Severe organic mitral valve regurgitation. "Severe organic mitral valve regurgitation" is defined as non-ischemic mitral valve regurgitation with an organic cause (intrinsic valve lesion) as determined by echocardiographic core-lab reading based on the for definition of severe MR as issued by the ESC guidelines [4]. For practical reasons, referring cardiologists can use an ESC guidelines based index that was validated in the investigator's core-lab (Jansen et al, Practical echocardiographic semi-quantitative scoring system to determine severity of mitral regurgitation. Abstract presentation at ESC Congress 2011 and annual spring congress 2012 Netherlands Society of Cardiology) Preserved left ventricular function, "Preserved left ventricular function" is defined as left ventricular ejection fraction >60% and left ventricular end-systolic dimension <45 mm (no indexed value, measured by echocardiography) 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, either on 12-lead ECG or holter-monitoring 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 Patients with moderate to severe kidney disease (estimated glomerular filtration rate (eGFR) less than 30 mL/min) Flail leaflet together with a left ventricular end systolic diameter (LVESD) ≥40 mm (no indexed value) | 0 |
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