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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, Heart Failure Inpatient admission for acute decompensated heart failure Left ventricular systolic or diastolic heart failure Owns a smartphone with a data plan Hospice or life expectancy less than 6 months Palliative inotrope use Heart transplant listed, or status post transplant Ventricular assist devise present, or awaiting placement Not being discharged to home Unable to provide consent or comply with the intervention Current enrollment in a remote monitoring/ telehealth program | 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, Bariatric Surgery Candidate Laparoscopic Sleeve Gastrectomy Obesity, Morbid were, patients between 18 to 65 years old, initial body mass index (BMI) 40 kg/m2 or BMI of 35 kg/m2 in the presence of additional comorbidity and failure of conservative treatment for 2 years 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, Sleep-disordered Breathing Snoring People with Marfan syndrome Age ≥ 18yrs Able and willing to provide informed consent Willing to sleep connected to research apparatus Unstable cardiovascular disease (CHF, myocardial infarction or revascularization procedures, and unstable arrhythmias) Uncontrolled hypertension (BP > 190/110) Underlying obstructive or other intrinsic lung disease Renal failure on dialysis Cirrhosis Pregnancy | 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 MVARC | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-65.0, Rheumatic Heart Disease Mitral Stenosis Rheumatic Mitral Stenosis Fibrosis; Heart ACE Inhibitor Patients with mitral valve stenosis or a combination aged more than 18 years undergo cardiac valve replacement operation with or without a tricuspid valve repair patients with systolic blood pressure (SBP) ≥ 100 mmHg and diastolic blood pressure (DBP) ≥ 60 mmHg passed in medication phase without side effect minimum 4 weeks until operation schedule Patients with congenital heart disease 2. patients with non-mitral valve surgery 3. patients with coronary artery bypass surgery 4. patients who refuse to join this study. 5. adults aged over 65 years or older 6. pregnant women 7. patients with autoimmune disease. 8. Patients with persistent hypotension (systolic blood pressure (BP) < 100 mm Hg) 9. severe aortic stenosis (aortic valve orifice < 0.75 cm2 ) 10. chronic renal dysfunction with serum creatinine > 2.5 mg/ dL, 11. known ACEI intolerance | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 60.0-85.0, Male Osteoporosis DXA BMD T-score < or = -2.0 at either lumbar spine (LS), femoral neck (FN) or total hip (TH) sites; or DXA BMD T-score < or = -1.5 with at least one additional important clinical risk factor for osteoporotic fracture [e.g., fragility fracture after age 50 years; parental history of hip fracture; history of hypogonadism, prior glucocorticoid therapy (>3 months prior), current smoking, prevalent vertebral fracture(s), or prior hyperthyroidism on stable treatment] At least 2 LS vertebral levels with reliable BMD values (i.e., at least 2 without compression or hardware) Metabolic bone disease other than osteoporosis (e.g., Paget's disease, hyperparathyroidism) Any osteoporosis drug therapy within 12 months; any prior course of TPTD for > or = 3 months; any history of IV bisphosphonate therapy; oral bisphosphonate therapy exceeding 3 months in past 2 years; oral bisphosphonate treatment exceeding 2 years ever; or use of denosumab (within the past 3 years or > 3 or = injections ever) Oral glucocorticoid use (> or = 5 mg prednisone) taken within 3 months prior to enrollment Hypercalcemia (albumin-corrected serum [Ca] >10.2 mg/dL), hypocalcemia (albumin-corrected serum [Ca] <8.8 mg/dL), elevated intact PTH level, or hypercalciuria (urinary Ca >300 mg/24 hours) at screening OH vitamin D levels <20 ng/ml or >80 ng/ml at screening Estimated glomerular filtration rate < 30 ml/min (chronic kidney disease (CKD) stage 4 or 5) Cancer within past 5 years except for non-melanomatous skin cancers History of skeletal radiation, prior history of osteosarcoma or bone metastases Substance abuse (>3 drinks/day), liver disease or impaired liver function (abnormal liver function tests defined as greater than 3 times the upper limit of normal), known cirrhosis, malabsorption Poorly controlled diabetes (A1c >9.0%) or current thiazolidinedione therapy | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Pain, Postoperative Knee Pain Chronic Subjects undergoing TKR Acceptance to participate ASA physical status II-III Age > 18 years Refusal to participate in the study Allergy to local anesthetics History of substance abuse | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 6.0-999.0, Univentricular Heart Children ≥ 6 years old and adults with a single ventricle according to the international classification ACC-CHD and who had a cardiopulmonary exercise test in the year during usual follow-up Patients refuse the use of medical data will be excluded | 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 2. Moderate-severe or severe mitral regurgitation (> 3+) For Degenerative MR: EROA ≥ 40 mm2 or regurgitant volume ≥ 60ml For Secondary MR: EROA > 30 mm2 or regurgitant volume > 45ml (i.e., MR ≥ moderate-severe or severe by ASE criteria) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent Any stroke/TIA within 30 days 2. Severe symptomatic carotid stenosis (> 70% by non-invasive imaging) 3. Active infections requiring antibiotic therapy 4. Active ulcer or gastro-intestinal bleeding in the past 3 months 5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. Patients in whom TEE is not feasible 7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. Patient is unable to comply with the follow-up schedule and assessments 9. Participation in another clinical investigation at the time of 10. Patient has known allergies to the device components or contrast medium 11. Patient cannot tolerate anticoagulation or antiplatelet therapy 12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 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): 18.0-999.0, Mitral Regurgitation Age ≥ 18 years 2. Moderate-severe or severe mitral regurgitation (≥ 3+) 3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV 4. Patient is under guideline directed medical therapy, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 5. Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability 6. Patient meets the anatomical for HighLife valve 7. Patient is willing to participate in the study and provides signed informed consent Any stroke/TIA within 30 days 2. Severe symptomatic carotid stenosis (> 70% by non-invasive imaging) 3. Active infections requiring antibiotic therapy 4. Active ulcer or gastro-intestinal bleeding in the past 3 months 5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion 6. Patients in whom TEE is not feasible 7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months. 8. Patient is unable to comply with the follow-up schedule and assessments 9. Participation in another clinical investigation at the time of 10. Patient has known allergies to the device components or contrast medium 11. Patient cannot tolerate anticoagulation or antiplatelet therapy 12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions 13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 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): 18.0-999.0, Mitral Regurgitation Aortic Regurgitation Age ≥18 years of age Able to give informed consent Referred for isolated aortic or mitral valve repair or replacement due to valve regurgitation Inability to provide consent Pregnancy Claustrophobia Metallic contraindications to MRI (e.g. noncompatible aneurysm clip etc) Known intracardiac shunt Planned concomitant cardiac surgical procedure such as coronary artery bypass, septal myomectomy, or other valve procedure More than mild mitral or aortic stenosis For patients enrolled with mitral regurgitation: greater than mild aortic regurgitation For patients enrolled with aortic regurgitation: greater than mild mitral regurgitation Hypertrophic cardiomyopathy | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Age >=18 yrs 2. able to give informed consent 3. Diagnoses of moderate or severe degenerative mitral regurgitation (based on the integrated approach recommended by the American Society of Echocardiography) Left ventricular ejection fraction <60% 2. Heart failure 3. Pulmonary hypertension (pulmonary artery systolic pressure >40mmHg at rest or >60mmHg with exercise as assessed by echocardiography) 4. Atrial fibrillation 5. Concomitant > mild aortic or mitral stenosis, >mild aortic or tricuspid or pulmonic regurgitation 6. Prior valvular heart disease surgery 7. Hypertrophic cardiomyopathy or an infiltrative cardiomyopathy 8. Unable to exercise on a treadmill 9. Symptomatic coronary artery disease 10. Comorbidities expected to impact functional capacity and confound symptom assessment (e.g COPD) 11. Expected lifespan of less than 2 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): 18.0-80.0, Functional Tricuspid Regurgitation Rheumatic mitral valve disease Surgery for mitral valve replacement Severe functional tricuspid regurgitation Moderate functional tricuspid regurgitation with annular dilatation > 40 mm Moderate functional tricuspid regurgitation with preoperative systolic pulmonary artery pressure (SPAP) >50 mmHg Patients with non-rheumatic mitral disease Combined mitral and aortic valve replacement Mitral valve repair Concomitant coronary artery or aortic surgery Mild or organic tricuspid regurgitation Emergency surgery Reoperations Invalid or missed data | 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 yrs 2. Moderate to severe (3+) or severe (4+) mitral valve regurgitation confirmed by echocardiography (defined as MR >2+); 3. NYHA functional class II-V (Appendix 3); 4. Anatomically suitable for mitral valve repair; 5. 40mm ≤LVESD≤55 mm; 25% ≤LVEF ≤60%; tolerable for small incision thoracic surgery; 6. Mitral valve diameter ≤45mm; 7. The independent expert committee of this study determined that surgical operation was contraindicated or high-risk, and the recommended reference standard was: surgical valve replacement with STS score ≥ 8； or surgical valve repair with STS score ≥ 6； or other risk factors (e.g., There are at least two moderate to severe indicators of weakness; potential operational disorders; at least major organ dysfunction that cannot be improved after surgery, etc.) 8. The subject or the subject's legal representative fully understand and agree to join to the clinic trial Echocardiographic evidence of intracardiac mass, thrombus or vegetation; 2. Severe mitral valve calcification; 3. Concomitant with greater than moderate aortic stenosis or regurgitation; 4. Mitral regurgitation caused by special pathological mechanisms, such as leaflet perforation and leaflet fissure; 5. Severe untreated coronary artery stenosis requiring revascularization; or with other cardiovascular disease requiring surgical treatment; 6. Hypertrophic cardiomyopathy with or without obstruction, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart diseases that cause heart failure in patients expect dilated cardiomyopathy; 7. Myocardial infarction was performed within 4 weeks before the intervention; 8. Any vascular intervention, cardiac surgery, cardiac resynchronization therapy (CRT, CRT-D), and an implantation of implantable cardioverter defibrillator (ICD) were performed within 30 days before the intervention; 9. Any heart transplantation, mitral valve surgery or percutaneous mitral valve operation were performed before the intervention; 10. Life expectancy is less than 12 months; 11. History of, or active, rheumatic heart disease; 12. Active phase of bacterial endocarditis; 13. The active infections require concurrent antibiotic treatment; 14. History of acute peptic ulcer or upper gastrointestinal bleeding within 3 months; 15. Dysplasia of the blood system, including granulocytopenia (WBC < 3×109/L), acute anemia (HB < 90g/L), thrombocytopenia (PLT < 50×109/L), hemorrhagic constitution, and coagulopathy； 16. Modified Rankin scale ≥4； 17. Pregnant or lactating women; 18. The subject is suffered from a disease which may cause difficulty in evaluating the treatment (e.g., cancer, infection, severe metabolic disease, psychosis, etc.); or special cases were evaluated by the local experimental center heart team as not suitable for the surgical application of this clinical trial instrument; 19. Participants who have participated in clinical trials of any drug and/or medical device within 1 month before this study; 20. In the judgment of the Investigator, patients were not compliant enough to complete the study as required | 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): 18.0-100.0, Pelvic Organ Prolapse Any patient planning to undergo surgery for anterior compartment prolapse, English speaking. - Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse. - | 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 Functional Mitral Valve Disease Cardiovascular Diseases Subject is 18 years of age or older Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed Subject has moderate to severe (3+) or severe (4+) functional mitral regurgitation confirmed by echocardiography core lab Subject is symptomatic (NYHA Class II-IV) despite guideline directed medical therapy, including CRT if indicated The local site heart team concurs that mitral valve surgery will not be offered as a first-line treatment option Subject is a candidate for annuloplasty based on the below as assessed by the investigative site (and confirmed by the Case Review Committee [CRC]): Left Ventricular Ejection Fraction (LVEF) ≥ 25% Left Ventricular End Diastolic Diameter (LVEDD) ≤ 65 mm Coaptation distance (i.e. tenting height) < 10 mm Absence of posterior wall aneurysm Subject has severe calcification of the mitral annulus or leaflets or other anatomic features that make the subject unsuitable for annuloplasty with the Millipede System in the judgment of the treating physician or subject does not have suitable mitral annular diameter (determined by CT) as per the Instructions for Use Transfemoral venous and transseptal access determined not to be feasible Subject is on the waiting list for a transplant or has had a prior heart transplant Subject has had a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 30 days prior to study enrollment Subject has had any percutaneous coronary, carotid, or other endovascular intervention within 30 days prior to study enrollment Subject has had carotid surgery within 30 days prior to study enrollment Subject has had any open coronary or vascular surgery (other than carotid surgery) within 3 months prior to study enrollment Subject has had a cardiac resynchronization therapy (CRT) device implantation within 3 months prior to study enrollment Subject has untreated clinically significant coronary artery disease requiring revascularization Any planned cardiac surgery within the next 12 months | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Mitral Regurgitation Mitral Valve Insufficiency 18 years or older 2. At least moderate to severe symptomatic mitral regurgitation 3. Life expectancy greater than 1 year post intervention 4. Able to give informed consent Patient not eligible for percutaneous mitral valve intervention | 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 Mitral Insufficiency Signed Informed Consent Form Subject had a successful MAR implantation in clinical investigation 2010-040 Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system | 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): 18.0-89.0, Hip Injuries All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing hip arthroscopy years old or greater Ability to read and speak English Revision surgery Oncologic etiology Arthroscopic hip surgery that involves procedures other than labral repair, acetabuloplasty, CAM-plasty, IT band windowing, Iliopsoas lengthening Patients with a current indication of narcotic use Individuals unable to provide informed consent Prisoners Pregnant women Minors/Individuals under 18 years of age | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 65.0-999.0, Mitral Valve Regurgitation Severe mitral valve regurgitation ≥ 3+ High surgical risk fot open mitral valve surgery Age ≥ 65 years old Life expectancy > 12 months As assessed by multidisciplinary cardiac team, patients who are not eligible for surgery Patients sign an informed consent form Previous cardiac mitral valve surgery Active infections requiring antibiotic therapy Clinically significant untreated Coronary Artery Disease (CAD) Pulmonary hypertension （Pulmonary systolic pressure > 70 mmHg） Patients with severe right heart failure Left ventricular ejection fraction <25% Diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis Dialysis patient Patients with severe coagulopathy Patients with contraindications to anticoagulant drugs | 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): 40.0-999.0, Mitral Regurgitation Adults (age ≥ 40 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with MitraClip TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording Women who are pregnant or believe they could be pregnant | 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, Systolic Heart Failure Stage D (Disorder) Mitral Regurgitation aged 18 years or older acute decompensated heart failure due to severe left ventricular systolic dysfunction combined with hemodynamically significant mitral regurgitation. Severe systolic dysfunction and hemodynamically significant mitral regurgitation are defined as left ventricular ejection fraction less than 35% and mitral regurgitant volume more than 45 ml (more than moderate degree), respectively cancer or other significant co-morbid diseases with expected life span less than 3 years adverse effects of hydralazine surgical interventions of mitral regurgitation will be done in follow-up period which change the course of native condition other valvular conditions other than mitral regurgitation with severity more than or equal to moderate degree, particularly mitral stenosis, and aortic regurgitation/stenosis lack of 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 Subjects is eligible to receive the MitraClip per the current approved MitraClip System IFU. (If any update or amendment on the IFU, the latest version of IFU shall be followed.) 2. Subject is 18 years-old or above. 3. Subjects who give consent for study procedure Subject cannot tolerate procedural anticoagulation or anti-platelet regimen. 2. Subject with active endocarditis of mitral valve. 3. Subject with rheumatic mitral valve disease. 4. Subject with echocardiographic evidence of intracardiac, IVC or femoral venous thrombus. 5. Subject is unlikely to survive the protocol follow up period of 12-months after device implant. 6. Subject has insufficient or lost ability to maintain their will and rights. 7. Subject is illiterate. 8. Pregnant or nursing subjects and those who plan pregnancy during the study follow-up period 9. Subject participates in another clinical study that may impact the follow-up or results of this 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): 0.0-999.0, Moderate Ischemic Mitral Regurgitation All patient with multi-vessel coronary artery disease with moderate degree of ischemic mitral regurgitation Patient undergone surgery using cardiopulmonary bypass Patient done on elective basis CABG done by off-pump technique patients not candidates for complete revascularization patients with other valvular affection other than mitral valve Patients done on emergency basis patient known to have Rheumatic valvular heart disease | 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): 40.0-85.0, Glaucoma Open-Angle Primary Cataract General 1. Male and female patients, from 40 to 85 years of age, inclusive. 2. Patient is able and willing to attend scheduled follow-up examinations as per routine care for 2 year post-operatively. 3. Patient is able to understand the information sheet and give informed consent. for the study eye: 4. An operable age-related cataract with BCVA of 6/9 or worse that is eligible for phacoemulsification. 5. A diagnosis of POAG or pigmentary glaucoma treated with hypotensive medications (eye drops for glaucoma). 6. A previously documented unmedicated intraocular pressure of > 21 mmHg (i.e. IOP > 21 mmHg prior to the commencement of glaucoma treatment). 7. An optic nerve appearance characteristic of glaucoma with either: 1. visual field loss (no worse than -12dB) identified on examination using Humphrey 24-2 SITA standard, or 2. (in patients where the VF exam is not confirmatory for glaucomatous defect) OCT retinal nerve fibre layer imaging supporting the ophthalmoscopy findings indicating a diagnosis of mild glaucoma. (If OCT findings are not confirmatory of glaucoma and both the visual field and the OCT are normal, the patient should not be enrolled). 8. Shaffer grade ≥2 in all four quadrants on gonioscopy. 9. Absence of peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities that could impair surgical access to the ciliary processes Diagnosis of Primary angle closure glaucoma. 2. Any diabetic retinopathy. 3. Previous history of Central Serous Retinopathy or Cystoid Macular Oedema in either eye. 4. Congenital or developmental glaucoma. 5. Secondary glaucoma (such as neovascular, uveitic, pseudoexfoliative, lens-induced, steroid-induced, trauma induced, or glaucoma associated with increased episcleral venous pressure). 6. Previous trabeculectomy, tube shunts, or any other prior subconjunctival filtration or cycloderstructive surgery. 7. Inability to complete a reliable 24-2 SITA Standard Humphrey visual field on the study eye at screening (fixation losses, false positive errors and false negative errors should not be greater than 33%). 8. Patients with advanced glaucoma or any patient where the risk to the patient of a washout of ocular hypotensive medications (eye drops for glaucoma) is assessed as unacceptable (i.e. where there may be a risk of damage to vision if treatment is stopped for the washout). 9. Best corrected visual acuity worse than 6/36 in the fellow eye (i.e. not the eye undergoing the study intervention). 10. A 24-2 SITA Standard Humphrey visual field mean deviation (MD) of worse than -12dB in the study eye. 11. Previous vitreo-retinal surgery. 12. Previous corneal surgery or clinically significant corneal dystrophy, e.g. Fuch's dystrophy (>12 confluent guttae). 13. Unclear ocular media preventing visualization of the fundus or anterior chamber angle. 14. Degenerative visual disorders such as wet age-related macular degeneration. 15. Clinically significant ocular pathology other than cataract and glaucoma. 16. Clinically significant ocular inflammation or infection within 1 month prior to screening. 17. Presence of extensive iris processes that obscure visualization of the trabecular meshwork. 18. Uncontrolled systemic disease that in the opinion of the investigator would put the patient's health at risk and/or prevent the patient from completing all study visits. 19. Current participation or participation within the past 30 calendar days in another investigational drug or device clinical trial (which includes the fellow eye). 20. Pregnant or nursing women, or women of child bearing age planning pregnancy or not using medically acceptable contraceptives. 21. Unwilling or unable to give informed consent/unwilling to accept randomisation. 22. Unwilling or unable to return for scheduled protocol visits. 23. Any not met | 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, Mitral Valve Prolapse Mitral Regurgitation Prolapsed or ruptured chordae Either degenerative or ischemic Patient with redo Mitral Valve surgery Patient with severe rheumatic mitral stenosis (MS) | 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, Marfan Syndrome Ectopia Lentis MFS patient, clinical diagnosis according to revised Ghent confirmed by FBN1 mutation Relatives of MFS patients with none of the clinical features of MFS and in whom testing for the familial FBN1 mutation was negative Patients who had surgery for ectopia lentis Patients for whom dilation was not optimal | 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, Pelvic Organ Prolapse Stage II-IV pelvic organ prolapse Bothersome bulge symptoms At least 725 MET-minutes/week on International Physical Activity Questionnaire Short Form English-speaking Undergoing treatment of prolapse Surgery occurring at least 7 days from date of randomization (to allow for collection of at least 7 days of preoperative accelerometer data) Able and willing to follow up at 3 months for in-office exam Enrollment in another research study of pelvic organ prolapse Concomitant non-urogynecologic surgery Planned further surgery in the next 3 months or anticipated treatment which would result in prolonged inactivity (such as a cancer diagnosis) 3 months postoperatively | 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, Tricuspid Regurgitation Severe tricuspid regurgitation, as assessed by the clinical site echocardiographer using the transthoracic echocardiography. 2. A history of LSVS, including one or multiple procedures of aortic and/or mitral valve repair and/or replacement. 3. Left ventricular ejection fraction (LVEF) >45%, systolic pulmonary artery pressure <60 mmHg with pulmonary vascular resistance <6 woods unit. 4. Age ≥ 18 years. 5. Able to sign Informed Consent forms TR due to: infective endocarditis, congenital tricuspid valve malformation, secondary to correction of congenital heart disease. 2. Left-sided valve dysfunction or coronary artery disease requiring concomitant procedures. 3. Prior surgical or percutaneous tricuspid valve intervention. 4. Evidence of an acute myocardial infarction in the prior 90 days 5. Contraindications to cardiopulmonary bypass or the expected operative mortality >30% (calculated by the Society of Thoracic Surgeons score or the EuroSCORE II). 6. Any comorbidity with life expectancy <2 years 7. Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study protocol. 8. Pregnancy 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): 21.0-95.0, Mitral Valve Insufficiency Key 1. Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+) 2. Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team 3. Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies 4. Age ≥ 21 5. Native mitral valve geometry and size compatible with the Half Moon TMVr implant 6. Anatomy suitable for transfemoral transseptal access with the Half Moon TMVr System 7. Willing to sign Informed Consent for participation in the study and return for all required post-procedure follow-up visits Key Prior transseptal intervention with occlusion device currently implanted 2. Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system 3. Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation 4. Prohibitive mitral annular or leaflet calcification 5. Diseased mitral anterior leaflet such as flail or prolapse 6. Left ventricular ejection fraction (LVEF) < 25%, or LVEF 25-30% in the presence of left ventricular end diastolic volume index (LVEDVi) >120mL/m2 as measured by resting echocardiogram within 30 days of the Index Procedure 7. Left ventricular end diastolic diameter (LVEDD) > 75mm 8. Pulmonary hypertension with resting pulmonary artery systolic pressures ≥ 2/3 systemic systolic pressure 9. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction 10. Severe tricuspid regurgitation 11. Prior mitral valve surgery or endovascular procedure, or need for other valve surgery/procedure 12. Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment 13. Prior stroke, TIA, or myocardial infarction within 90 days 14. Need for coronary revascularization 15. Severe symptomatic carotid artery stenosis 16. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc 17. Need for emergent surgery 18. Endocarditis within 6 months 19. Subject is unwilling or unable to adhere to the protocol recommended anticoagulation treatment 20. GI bleeding within 6 months 21. History of bleeding diathesis or coagulopathy or patient will refuse blood transfusion 22. Hemodynamic instability requiring dependency on either inotropic agents or mechanical circulatory support 23. Platelet count of <75,000 cells/mm3 24. Renal insufficiency (Creatinine > 2.5 mg/dL) 25. Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 2 weeks after discontinuation of antibiotics) 26. Contraindication to transesophageal echocardiography (TEE) 27. Known hypersensitivity or contraindication to study or procedure medications/contrast which cannot be adequately managed medically 28. Pregnant, nursing or planning to be pregnant. (Female participants of childbearing potential must have a negative pregnancy test prior to enrollment) 29. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint | 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): 19.0-999.0, Mitral Valve Insufficiency Mitral Regurgitation Mitral Valve Regurgitation Significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation Age 19 and more Written informed consent Patients who cannot tolerate procedural anticoagulation or post-procedural antiplatelet regimen Active endocarditis of the mitral valve Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus | 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, Mitral Regurgitation Each subject is required to meet all of the following 1. Patient is >/= 21 years old. 2. Presence of severe degenerative mitral regurgitation with isolated mid-segment posterior leaflet prolapse by echocardiographic study. 3. Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without undue leaflet tension, based on the judgment of the Echocardiographic Core Lab. 4. Patient competent to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation Patients will be excluded if ANY of the following apply: 1. Functional mitral regurgitation (FMR). 2. Evidence of anterior or bileaflet prolapse. 3. Severe mitral annular calcification (MAC). 4. Moderate or greater leaflet calcification. 5. Fragile or thinning apex (e.g. LV aneurysm). 6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to the trial procedure. 7. Planned cardiac or peripheral vascular procedures within 30 days after the trial procedure. 8. Requirement for concomitant cardiac surgery. 9. Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg). 10. Severe aortic stenosis or insufficiency. 11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid regurgitation are not excluded.) 12. Left or right ventricular ejection fraction (LVEF or RVEF) <30% as measured by the core lab. 13. Any history of endocarditis. 14. Contraindication to cardiac surgery, including hostile chest or history of mediastinal radiation. 15. Previous structural heart intervention (e.g. any heart valve replacement or repair procedures) with the exceptions of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). 16. Stroke within 30 days prior to index procedure. 17. ST segment elevation myocardial infarction (STEMI) requiring intervention within 30 days prior to index procedure. 18. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or MELD score of ≥ 13]). 19. Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2). 20. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g. requiring inotropic support or mechanical support devices). 21. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL). 22. Refuse blood products. 23. Planned treatment with any other investigational device or procedure through 1-year follow-up, or who are currently participating in an investigational drug or device trial. 24. Carotid stenosis ≥ to 80% at time of enrollment. 25. Rheumatic heart disease including rheumatic mitral stenosis. 26. Pregnant or lactating at the time of enrollment (women of childbearing age should have negative pregnancy test within 72 hours of surgery) or planning pregnancy within the next 12 months. 27. Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator. 28. Condition or conditions that, in the opinion of the Investigator, precludes participation, including willingness to comply with all follow-up procedures. 29. Contraindication for transesophageal echocardiography (TEE), including esophageal spasm, esophageal stricture, esophageal laceration, esophageal perforation, esophageal diverticula (e.g. Zenker's diverticulum). 30. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or appendage thrombus, myxoma, or vegetation). 31. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen. Intra-operative No longer meets based on intra-operative assessment | 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 Subject is > 18 years old 2. Presence of severe MR as read on a transthoracic echocardiographic study 3. Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient committee and the operating surgeon 4. Degenerative mitral valve disease with mid-segment P2 prolapse 5. 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 Patient is of the age where further growth is expected 2. Active endocarditis 3. Left ventricular or left atrial appendage thrombus 4. Severe mitral annular and/or leaflet calcification 5. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen 6. Mitral stenosis 7. Functional Mitral Valve disease 8. Previous mitral valve replacement surgery 9. Fragile or thinning apex 10. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum) 11. Patient is pregnant or lactating | 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 Patients with mitral regurgitation that are assigned to the MitraClip implantation by an interdisciplinary heart team according to current guidelines contraindication to MRI examination (e.g. pace-maker, implanted metal material, claustrophobia) pregnancy unable to consent no transtemporal window | 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): 0.75-999.0, Chronic Coronary Syndrome Heart Failure AMD and Macular Edema Chronic Respiratory Failure Hemophilia Malignant Hemopathy Multiple Sclerosis Horton's Disease patients with one of the following chronic diseases: chronic coronary syndrome, heart failure, multiple sclerosis, Horton's disease, AMD, malignant haemopathy, chronic respiratory failure (idiopathic fibrosis, PAH, haemophilia) and already registered in one of the 8 Burgundian registries/cohorts deceased patient, patient cannot be reached after >3 telephone calls, patient or caregiver does not speak French to carry out telephone interviews | 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, Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse Subjects who are clinically suitable for treatment with the System, as per the Instructions for Use (IFU), will be evaluated for in the registry N/A | 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, Ischemic Mitral Regurgitation Functional Mitral Regurgitation Moderate or greater (2+) ischemic Functional Mitral regurgitation by 2D echocardiography using an integrative method Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation) Patient is 22 years of age or older Patient is willing and able to sign Informed Consent Form Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States Any evidence of structural (chordal or leaflet) mitral valve disease Inability to derive ERO, or by TTE Prior surgical or percutaneous mitral valve intervention Contraindication to cardiopulmonary bypass (CPB) Clinical signs of cardiogenic shock Treatment with chronic intravenous inotropic therapy Severe, irreversible pulmonary hypertension in the judgement of the investigator ST segment elevation requiring intervention within 7 days prior to randomization Congenital heart disease (except PFO or ASD) Evidence of cirrhosis or hepatic synthetic failure | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-70.0, Mitral Prosthetic Valve Stenosis and Regurgitation Age<70 years Symptoms of heart failure NYHA class>ll Severe mitral bioprosthetic dysfunction (stenosis, regurgitation, mixed) defined by echocardiography Heart team (including cardiac surgeon) agree on including assessment that transeptal, transcatheter mitral valve replacement (TsMVR) and redo surgical mitral valve replacement (rSMVR) are appropriate The study patient or the study patient's legal representative informed of the nature of the study, agreed to its provisions and provided written informed consent as approved by the Institutional Review Board (IRB) center The study patient agreed to comply with all required post procedure follow-up visits including annual visits through 10 years and analysis close date visits, which was conducted as a phone follow-up Heart team agreed (a priori) on treatment strategy for concomitant coronary disease (if present) Patient agreed to undergo redo surgical mitral valve replacement (rSMVR) if randomized to control treatment Heart Team assessment of inoperability (including examining cardiac surgeon) Hostile chest Evidence of an acute myocardial infarction < 1 month (30 days) before the intended treatment [defined as: Q wave Ml, or non-Q wave Ml with total creatine kinase (CK), creatine kinase MB isoform (CK-MB) and/or cardiac troponin elevations (WHO definition)] Concomitant severe valvular disease (aortic, tricuspid or pulmonic) requiring surgical intervention Mitral mechanical prosthesis or mitral valve rings Preexisting mechanical or bioprosthetic valve in other position with dysfunction Complex coronary artery disease: unprotected left main coronary artery, Syntax score > 32 (in the absence of prior revascularization) Any therapeutic invasive cardiac procedure resulting in a permanent implant that is performed within 30 days of the index procedure (unless part of planned strategy for treatment of concomitant coronary artery disease). Implantation of a permanent pacemaker is not an Patients with planned concomitant surgical or transcatheter ablation for atrial fibrillation Leukopenia (WBC < 3000 cell/mL), acute anemia (Hgb< 9 g/dL), thrombocytopenia (Pht< 50,000 cell/mL) | 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, Residual Tricuspid Regurgitation Left-sided Cardiac Surgery Mitral valve or aortic valve diseases requiring surgical intervention No pathologic changes in TV leaflets No previous tricuspid valve surgery Patients with incomplete data Patient with history of previous cardiac surgery Patient with congenital anomalies of mitral or tricuspid valve Patient with both tricuspid stenosis and 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 Surgery Aged at least 18, willing to complete the study follow-up, having signed the informed consent for participation and data management Severe mitral regurgitation due to degenerative disease with indication to mitral repair surgery If of female gender, being neither pregnant nor lactating Previous right chest surgery or severe right intrapleural adhesions Diameter of femoral arteries equal or lesser than 6 mm Left ventricular systolic dysfunction (LVEF <60%) Severe right ventricular dysfunction Aortic valve regurgitation >1+/4+ Pulmonary artery hypertension (PASP >50 mmHg) Chest deformities preventing either robotic-assisted or minimally invasive video-assisted 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): 20.0-60.0, Probiotics Sub-project 1 Full-time nursing staff from Mackay Memorial Hospital, including wards and special units Age 20 to 60 years old Perceived Stress Scale (PSS) 10 questions version, with a cutoff point of 27 points or more Have taken or are receiving antibiotics within one month Probiotics used in powder, capsule or tablet in two weeks (except for Yogurt, Yogurt, Yakult and other related foods) Patients with hepatobiliary gastrointestinal tract who have undergone surgery Patients with past or present inflammatory bowel disease Those with a history of cancer Those who are allergic to lactic acid bacteria Currently taking medication to treat acute or chronic diseases or sleep disorders Sub-project 2 Age 20 to 60 years old Perceived Stress Scale (PSS) 10 questions version, with a cutoff point of 27 points or more | 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 Valve Heart Disease Heart Valve Diseases Mitral Valve Disease Mitral Disease Age 18 years or older. 2. Severe functional mitral regurgitation (≥ Grade 3+). 3. NYHA functional Class ≥ II. If Class IV, patient must be ambulatory. 4. Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days. 5. Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team. 6. Able to complete quality-of-life assessment (KCCQ). General Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement. 2. Life expectancy <1 yr due to noncardiac conditions. 3. Active endocarditis. 4. Active systemic infection. 5. Modified Rankin Scale ≥4 disability. 6. Hemodialysis/ chronic renal failure (eGFR < 35 mL/min/m2). 7. Pulmonary arterial hypertension (fixed PAS < 60mmHg). 8) COPD on home oxygen. 9) Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo or hyper-coagulable states). 11) Severe connective tissue disease under chronic immunosuppressive or cortisone therapy. 12) Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives. 13) Participating in other investigational studies likely to confound the results or affect the study. 14) Unable to consent. 15) Unable or unwilling to comply with study Follow-up. 16) Patients classified as "vulnerable patients". Cardiovascular Myocardial infarction during prior 30 days. 2. Stroke or TIA during prior 30 days. 3. Severe extracardiac arteriopathy (safety measure for extra-circulatory support if surgical conversion is needed). 4. Prior mitral valve treatment (e.g. valve repair or replacement, MitraClip, etc.), and/or anticipated mitral valve treatment prior to enrollment. 5. Prior surgical mechanical valve AVR. 6. Prior TAVI. 7. Need for any cardiovascular surgery or intervention (other than for MV disease) within 30 days. 8. CRT or ICD implanted in previous 30 days. 9. Cardiogenic shock, hemodynamic instability, Systolic Blood Pressure <90mmHg, Inotropic dependent or IABP/mechanical circulatory support. 10. CABG or PCI within previous 30 days. 11. Adequately treated for cardiac condition per applicable standards, such as for coronary artery disease, left ventricular dysfunction, mitral regurgitation, or heart failure. No need for revascularization. 12. Prior or planned heart transplantation (UNOS status 1). 13. Physical evidence of right-sided congestive heart failure: 1. Patients with ascites. 2. Patients with anasarca (generalized edema / hydropsy). Procedural Chest condition that prevents transapical access. 15. Known hypersensitivity or contraindication to procedural or post-procedural medication (e.g., contrast solution, anticoagulation therapy). 16. Documented hypersensitivity to nickel or titanium. Cardiac (evaluated by Core Labs): 1. Left ventricular EF ≤ 30% by imaging. 2. Severe mitral annular calcification, severe mitral stenosis, valvular vegetation or mass. 3. Extensive mitral flail leaflets. 4. Left ventricular thrombus, mass, or vegetation. 5. Left ventricular end-diastolic diameter > 7.5 cm. 6. Severe right ventricular dysfunction. 7. Significant intracardiac shunt. 8. Anatomic ineligibility for valve as determined by the Screening Committee | 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): 0.442-0.615, Infant, Premature, Diseases Birth weight between 750 g-1500 g ≤ 32 weeks gestational age at birth. GA will be determined by an ultrasound scan or the neonatologist's estimate, with consideration to maternal date Subject has been classified as appropriate for GA (AGA) Enteral feeding of human milk must be initiated by 21 days of life for infants with a birthweight of 750-1000 g (birth date is day of life 0) and initiated by 14 days of life for infants with a birthweight of 1.0 5 kg birthweight Mother agrees to feed the infant human milk as the exclusive feeding during the study period. Human milk may be mothers own or donor milk, plus Singleton or twin births only Serious congenital abnormalities or underlying disease that may affect growth and development minute APGAR: 5 4 Steroids used within the past 5 days Grade Ill or IV periventricular/ intraventricular hemorrhage (PVH/IVH) Maternal cocaine, alcohol or opioid abuse during pregnancy or currently or if the mother or infant is currently receiving treatment for HIV infection Infant major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia) Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life Infant has any other condition that, in the opinion of the investigator, compromises the ability to draw inference about the ability of the to support growth | 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): 0.083-18.0, Mitral Valve Insufficiency Patients with mitral regurgitation heart disease. 2. Patients with an age range of 1 day years 3. Patients with mitral regurgitation heart disease with atrial septal defects 4. Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD) Patients refuse to participate in the study. 2. Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan. 3. Reoperation mitral valve surgery. 4. History of abnormalities in the central nervous system / preoperative stroke. 5. Patients with severe pulmonary hypertension 6. Patients with small left ventricles (LV smallish) 7. History of pulmonary resuscitation (CPR) before surgery. Dropout 1. The patient fails to complete the entire examination procedure. 2. Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively. 3. Using extracorporeal life support (ECMO) device after surgery. 4. History of intra-operative CPR | 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, Valvular Disease Valvular Heart Disease Aortic Valve Stenosis Mitral Insufficiency and Aortic Stenosis Mitral Stenosis Coronary Artery Disease Chronic Kidney Diseases Valvular heart disease in moderate and severe stages Age < 18 years old | 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, Marfan Syndrome patient with Marfan syndrome and followed up at Bichat Claude Bernard hospital, Paris. Marfan syndrome should be diagnosed according to the Ghent nosology revised in 2010 Patient taking protective treatment for the aorta (beta blocker, calcium channel blocker, ACE inhibitor, angiotensin II receptor antagonist) Valid patient, able to return to consultation and carry out functional assessments and personalized physical training at home Patients operated prophylactically on the ascending aorta may be included at a distance > 6 months from their surgery Myocardial pathology other than Marfan syndrome Thoracic aorta dissection Aortic diameter > 45 millimeters Uncontrolled high blood pressure at rest (systolic blood pressure > 140 Millimeter of mercury and diastolic blood pressure > 90 Millimeter of mercury) Increase in systolic blood pressure > 160 Millimeter of mercury during exercise Pregnancy at the time of the study | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Covid19 Pregnancy Complications Premature Rupture of Membrane Abruptio Placentae Prelabor Rupture of Membranes Stillbirth - Patients eligible for follow-up o target population will be any pregnant woman who is suspected or needs to be ruled out as having a SARS-CoV-2 infection at any time during pregnancy with positive test results for SARS-CoV-2 by PCR. Information regarding each pregnant woman's demographic characteristics, comorbidities and current obstetric history was extracted from the medical history and the patient interview; subsequently, age and race were categorized according to the classification used by the Center for Disease Control and Prevention (CDC) (17). For the selection of the control group to be collected in the same database, patients with a negative COVID-19 delivery diagnosed by PCR screening at delivery, or less than 3 days before, were considered Pregnant women under the following conditions will be excluded from the registry Inability to give informed consent in the absence of a legal representative If, in the opinion of the researcher, findings in the physical examination, anomalies in the results of the laboratory tests or other medical, social or psychosocial factors could have a negative influence Loss of follow-up data prior to 6 weeks postpartum | 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): 19.0-99.0, Severe Aortic Stenosis or Severe Aortic Regurgitation Age ≥ 19 yrs Severe aortic stenosis or severe aortic regurgitation Agree to consent for self Can follow-up for the next 2 years Pre-existing acute kidney injury Pre-existing end stage kidney disease: estimated glomerular filtration rate (eGFR) ≤15 ml/min/1.73m2 or receiving renal replacement therapy On ECMO or IABP Life expectancy < 12 months 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): 18.0-110.0, Mitral Valve Regurgitation Mitral Valve Stenosis Tricuspid Valve Regurgitation Age above 18 years and consentable Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision Written informed consent Patient's inability to fully cooperate with the protocol | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-75.0, Heart Failure Part A will healthy men and non-pregnant, non-lactating females of non-childbearing potential with a body mass index (BMI) of 18-30 kg/m^2 and a weight of 60-100 kg. One cohort will require participants be of Japanese descent Part B will men and non-pregnant, non-lactating females of non-childbearing potential with a BMI of 18-40 kg/m^2 and a weight of 60-120 kg with a diagnosis of New York Heart Association (NYHA) Class I-III on stable medical therapy for at least 12 weeks. The HFrEF will be defined as those with EF ≤ 40% and HFpEF defined as EF ≥ 50%, both with either N-terminal prohormone of brain natriuretic peptide (NT-proBNP) > 125 pg/mL or BNP > 100 pg/mL Both Part A and Part B will subjects with any of the following Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug or planned surgical procedure before study completion History of vascular and left ventricular aneurysms or prior dissections Any history of joint hypermobility, Marfan's syndrome, or any connective tissue disorder Clinical signs and symptoms consistent with Coronavirus disease-19 or confirmed infection within the last 4 weeks History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity injection devices or to drugs with a similar chemical structure or class to AZD3427 or any component of AZD3427 In addition, Part A will subjects with any of the following Alanine Aminotransferase (ALT) > Upper limit of normal (ULN) Aspartate Aminotransferase (AST) > ULN Total bilirubin > ULN (unless due to Gilbert's syndrome) Creatinine > ULN | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 0.0-999.0, Aortic Stenosis Mitral Regurgitation Pulmonary Hypertension Heart Failure, Systolic Cardiovascular Diseases Coronary Artery Disease Normal Sinus Rhythm LV systolic function >53% Known history of carotid artery disease Moderate or greater valvular disease in Group 1 Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc) Active arrhythmia Reduced Ejection Fraction (< 35%) other than Group 4 Hearing loss | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Tricuspid Regurgitation Pre-Inclusion 1. Age > 18 years 2. Symptomatic secondary (at least) severe TR (Carpentier Type IIIB (restrictive) and / or I (tricuspid annulus dilation)) stable for at least 30 days 3. NYHA functional class II to IV without cirrhosis and/or ascites 4. Signs of heart failure in the previous 12-months with or without having been hospitalized 5. Stable optimized medical and/or interventional treatment 6. Ineligible for corrective action on the valve by surgical approach after a specialized multidisciplinary consultation ("heart team") including at least a cardio-thoracic surgeon, an interventional cardiologist, an imaging-cardiologist and an Anesthesiologist). 7. Signature of an informed consent Definitive 8. Central core-laboratory analysis : TR characterized before Implantation by at least one of the following Regurgitation volume > 45 mL / beat Surface of the regurgitant orifice > 40 mm² Vena contracta> 7mm Gap between leaflets ≤ 7 mm Then after the TR severity grading; the Clinical Committee will valid the inclusion. Non 1. Patient treated with Mitraclip or other percutaneous approach on the mitral valve in the past 3-month 2. Any prior tricuspid valve procedure that would interfere with placement of the Triclip device 3. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may Tricuspid valve anatomy not evaluable by TTE and TEE Active endocarditis Evidence of calcification in the grasping area Evidence of stenosis (mean pressure gradient > 5 mmHg or surface area ≤1cm² Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets | 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 Tricuspid Valve Insufficiency Heart Valve Interventional treatment of severe tricuspid regurgitation (isolated or in combination with another interventional treatment) with a CE certified product for tricuspid valve repair Informed consent corresponding to of Good Clinical Practice and the decleration of Helsinki as well as to standards of the local ethic commission No agreement to participation 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): 18.0-999.0, Degenerative Mitral Valve Disease 18 years of age or older 2. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure 3. Patient must present with an STS Score less than 10% 4. High surgical risk for conventional mitral repair or replacement due to morphological (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure 5. Patient is approved by an independent Patient Committee 6. New York Heart Association (NYHA) Functional Class III or IV 7. Patient willing to participate in study and provide signed IRB/EC-approved informed consent 8. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits 9. Women of child-bearing potential have a negative pregnancy test Severe tricuspid regurgitation 2. Severe aortic stenosis or insufficiency 3. Severe mitral annulus calcification 4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification 5. Implanted vena cava filter 6. Femoral veins with severe angulation and calcification 7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan. 8. Active infection or endocarditis 9. Previous mitral valve surgery 10. Prior orthotopic heart transplantation 11. Pulmonary artery systolic hypertension > 70mmHg 12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus 13. Left ventricular ejection fraction (LVEF) < 30% 14. Implant or revision of any pacing device < 30 days prior to intervention 15. Symptomatic coronary artery disease treated < 30 days prior to study procedure 16. Myocardial infarction requiring intervention < 30 days prior to study procedure 17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis 18. Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure 19. Stroke < 180 days prior to study procedure 20. Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis 21. Cardiogenic shock at time of enrolment 22. Hemodynamic instability requiring inotropic support or mechanical heart assistance 23. Concurrent medical condition with a life expectancy of less than 2 years 24. Pregnancy at time of enrolment 25. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL) 26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated 27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments 28. Emergency situations 29. Company employees or their immediate family members 30. Patient is under guardianship 31. Patient is participating in another clinical study for which follow-up is currently ongoing | 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, Degenerative Mitral Valve Disease 18 years of age or older 2. Greater than moderate degenerative mitral regurgitation (Grade 3+ or higher) as confirmed by transesophageal echocardiography (TEE) within 90 days prior to study procedure 3. Patient must present with an STS Score less than 10% 4. High surgical risk for conventional mitral repair or replacement due to morphological (e.g. leaflet or annulus calcifications), but operable, as assessed by the local heart team comprised of a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in treating mitral valve disease and heart failure 5. New York Heart Association (NYHA) Functional Class III or IV 6. Patient willing to participate in study and provide signed IRB/EC-approved informed consent 7. Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits Severe tricuspid regurgitation 2. Severe aortic stenosis or insufficiency 3. Severe mitral annulus calcification 4. Diseased mitral anterior leaflet such as flail / prolapse/ heavy calcification 5. Implanted vena cava filter 6. Femoral veins with severe angulation and calcification 7. Contraindication for transesophageal echocardiography (TEE) or MDCT scan 8. Active infection or endocarditis 9. Previous mitral valve surgery 10. Prior orthotopic heart transplantation 11. Pulmonary artery systolic hypertension > 70mmHg 12. Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus 13. Left ventricular ejection fraction (LVEF) < 30% 14. Implant or revision of any pacing device < 30 days prior to intervention 15. Symptomatic coronary artery disease treated < 30 days prior to study procedure 16. Myocardial infarction requiring intervention < 30 days prior to study procedure 17. Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis 18. Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure 19. Stroke < 180 days prior to study procedure 20. Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis 21. Cardiogenic shock at time of enrolment 22. Hemodynamic instability requiring inotropic support or mechanical heart assistance 23. Concurrent medical condition with a life expectancy of less than 2 years 24. Pregnancy at time of enrolment 25. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL) 26. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated 27. Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments 28. Emergency situations 29. Company employees or their immediate family members 30. Patient is under guardianship 31. Patient is participating in another clinical study for which follow-up is currently ongoing | 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 clinically significant mitral insufficiency patient underwent screening for TMVI echocardiography data at baseline (and after TMVI, E2E and surgery) follow-up of at least 30 days age under 18 years | 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, Contrast-induced Acute Kidney Injury Acute Coronary Syndromes Urgent or immediate (within 2 hours) coronary procedure with iodinated contrast media administration in the setting of an acute coronary syndrome: ST-Elevation Myocardial Infarction (according to Fourth Universal Definition of Myocardial Infarction); High-risk Non-ST-Elevation Myocardial Infarction (according to current guidelines): 1. Refractory angina, 2. Signs or symptoms of heart faiklure or new or worsening mitral regurgitation, 3. Hemodynamic instability, 4. Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy, 5. Sustained ventricular tachycardia or ventricular fibrillation, 6. Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation Women who are pregnant Recent contrast media exposure: contrast media exposure within 48 hours End-stage chronic kidney disease on chronic dialysis: both haemodialysis and peritoneal dialysis Multiple myeloma Current enrolment in any other study when enrolment in the IV would involve deviation from either protocol | 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): 20.0-34.0, Child Development Child Obesity Child Behavior Nutritional and Metabolic Diseases Asthma in Children Cardiovascular Risk Factor Bone Loss Not pregnant, resident in Southampton UK GP requested no contact | 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): 7.0-25.0, Marfan Syndrome Patient aged between 7 and 25 years old with Marfan Syndrome or related according to Ghent For minors, no oral opposition from the holders of parental authority and consent of the minor For adults, no oral opposition collected Patient affiliated to a social security scheme or equivalent Inability of the patient to understand the content of the TEP sessions or the questionnaire about quality of life (non-French speaking, severe intellectual disability) Patient who has already participated in a TEP session for his pathology Protected adult: patient under legal guardianship or curator protection | 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): 18.0-120.0, Surgical Site Infection Risk Assessment Cardiac Surgery >/= 18 years old at the time of surgery; and 2. had a primary surgery (CABG, valve surgery or both) in the UK cardiac centres patients undergoing grown-up congenital heart disease related surgery; 2. patients with concurrent aortovascular surgery; 3. patients who had ventricular-assist device (VAD), haemolung, impellar and/or extracorporeal membrane oxygenator (ECMO) before and/or after cardiac surgery; 4. patients who had an open-chest immediately after surgery | 1 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-999.0, Atrial Fibrillation Venous Thromboembolism Heart Valve Diseases At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment Demonstrate the willingness and ability to test their own INR using a home INR monitoring device or have same-day access to clinic-derived INR results (e.g., via electronic medical record secure messaging) Willing to make independent decisions about warfarin dosing based on INR results Able to perform INR tests at least every 2 weeks Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms Have an anticipated duration of warfarin therapy of at least 6 months Goal INR range other than 2.0-3.0 or 2.5-3.5 Known poor adherence to warfarin therapy Non-English speaking Inability or refusal to provide 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): 18.0-75.0, Mitral Regurgitation Mitral Valve Insufficiency Mitral Valve Prolapse Elective mitral valve repair or replacement Planned minimally invasive approach Non-English speaking Emergency surgery Planned or unplanned sternotomy Previous history of sternotomy and cardiac surgery Allergy to ropivacaine Patients taking more than 60 OMEs per day Patients with coagulopathy or taking anticoagulant with laboratory findings contraindicated for ESP catheter | 2 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-120.0, Marfan Syndrome Marfan Syndrome Cardiovascular Manifestations >/= 18 years old at the time of surgery Identified MFS in the HES database using the ICD diagnosis code Q874 between January 2010 December 2019 Had an aorto-vascular surgery in England and Wales, as identified in the NICOR Adult Cardiac Surgery database < 18 years old at the time of 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): 60.0-999.0, Mitral Valve Regurgitation Subjects of age ≥ 60 years; 2. Subjects with primary or secondary severe symptomatic mitral valve regurgitation; 3. Subjects with severe, symptomatic mitral regurgitation and who have been evaluated by a multidisciplinary Heart Team and deemed to be ineligible for conventional valve surgery and not eligible for transcatheter repair; 4. Subjects with a left ventricular ejection fraction ≥ 30%; 5. Subjects in NYHA functional classes III to IV; 6. Subjects who have clearly accepted participation in a clinical evaluation and who have signed the informed consent; 7. Subjects who are willing to undergo all the medical check-ups and instrumental examinations and laboratory tests that are part of this present protocol; 8. Patients not planning to transfer abroad Clinical (preoperative screening) 1. Subjects involved in other clinical assessments for drugs or devices that could interfere or alter the study endpoints; 2. Subjects with clinical/anatomical conditions unsuitable for a transapical surgical approach; 3. Subjects who have previously undergone implantation of a transcatheter aortic valve prosthesis; 4. Subjects with previous implantation of a mitral heart valve prosthesis; 5. Subjects with previous implantation of a mitral annuloplasty ring; 6. Subjects needing emergency or life-saving interventions; 7. Subjects with a heavily calcified mitral annulus and/or anterior mitral leaflet; 8. Subjects with active infection or endocarditis (suspect endocarditis included); 9. Subjects with echocardiographic evidence of intracardiac mass or thrombus; 10. Subject which suffered an acute myocardial infarction within 30 days of the intended treatment (defined as: Q wave MI, or non-Q wave MI with elevation of CK-MB ≥ 3 times normal in the absence of pathological Q waves), if no assay for CK-MB was performed, elevation of CK level to >2 times normal without new Q waves, or elevated Troponin level is also considered a non-Q wave MI); 11. Subjects with an active peptic ulcer or upper GI bleeding within the prior 30 days; 12. Subjects with a documented allergy towards contrast media; 13. Subjects that have neurological disease severely affecting ambulation or day to day functioning; 14. Subjects with any stroke within the prior 30 days; 15. Subjects with senile dementia, according to the advice from a specialized neurologist; 16. Subjects in whom transesophageal echocardiography (TEE) is contraindicated since TEE is used for both preoperative screening and guidance during implant procedure Echographic (preoperative screening) 17. Subjects with left ventricular apex aneurysm; 18. Subjects with aorto-mitral angle <120°; 19. Subjects with a systolic/diastolic mitral valve area assessed compatible with the sizing policy matrix defined by the Sponsor Computerized Tomographic (CT) (preoperative screening) 20. Subjects with ventricular morphology (position of papillary muscles, ventricular wall hypertrophy) unsuitable with the study valve design; 21. Subjects with aorto-mitral angle <120°; 22. Subjects with a systolic/diastolic mitral valve area assessed compatible with the sizing policy matrix defined by the Sponsor | 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): 18.0-120.0, Marfan Syndrome Marfan Syndrome Cardiovascular Manifestations >/= 18 years old; 2. have validated diagnosis of MFS (using revised Ghent criteria); 3. diagnosed with aorto-vascular manifestations <18years old 2. Unable or unwilling to give written informed consent. 3. Inability to understand written and/or verbal English | 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): 18.0-120.0, Marfan Syndrome Marfan Syndrome Cardiovascular Manifestations >/= 18 years old at the time of surgery; 2. have validated diagnosis of MFS (using revised Ghent criteria); 3. having aorto-vascular surgery <18years old at the time of surgery 2. Unable or unwilling to give written informed consent. 3. Inability to understand written and/or verbal 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): 18.0-40.0, Twin Pregnancy; Body Mass Index; Weight Gain; Pregnancy Outcome Age 18 ~ 41 years old The gestational age of the first diagnosed twin pregnancy is ≤10weeks Double chorionic double amniotic sac pregnancy with heart disease, liver disease, kidney disease, complications (chronic hypertension, hyperthyroidism, diabetes and others ), genetic diseases, psychological and mental diseases with history of habitual abortion and cervical insufficiency | 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 Disease Heart Valve Diseases Structural Heart Abnormality adult patients patients admitted to hospital undergoing percutaneous cardiac procedure patients able to give informed consent age <18 years refuse to give 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): 0.0-999.0, Adverse Maternal and Neonatal Outcomes all women presenting for pregnancy-induced hypertension in Renji Hospital Affiliated to Shanghai Jiaotong University from January 2013 to January 2020 cesarean section operation | 0 |
34 year old woman with Marfan's syndrome and known severe mitral valve prolapse with regurgitation, who was planned for a MV repair but was lost to follow-up. She remains symptomatic and is now prepared to undergo mitral valve repair/replacement surgery. EF of 65% on TTE. Past Medical History: Marfans Syndrome MVP with severe mitral regurgitation Gastric reflux disease History of gestational diabetes mellitus Hypertension with pregnancy Obesity c-section x 2 laser eye surgery cataract surgery foot surgery (shorten bone length) | eligible ages (years): 18.0-60.0, Obesity BMI over 35 and obesity related disease BMI over 40 age between 18-60 years agrees to participate in the study age under 18 years or over 60 years abundant adhesions discovered during the surgery active upper gastrointestinal ulcer disease prior bariatric surgery active symptomatic reflux disease active psychiatric disease (eg psychosis) | 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 Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use. 2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits. 3. Patient provides written informed consent prior to any study-specific procedure Patient is in another clinical study that may impact the follow-up or results of this study. 2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period. 3. Patient is under the age of 18 or age of legal consent. 4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements | 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 Eighteen (18) years of age or greater Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail Intermediate or high surgical risk for mitral valve repair History of rheumatic heart disease History of prior endocarditis History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging | 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 Coronary Artery Disease Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017 American Society of Echocardiography (ASE) guidelines for noninvasive evaluation of native valvular regurgitation. 2. Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis. 2. Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture. 3. Age < 18 years. 4. Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team. 5. Need for a concomitant surgical procedure, excluding Coronary artery bypass grafting (CABG), tricuspid valve repair, Patent foramen ovale (PFO) closure, Atrial septal defect (ASD) closure and Maze procedure. 6. Prior mitral valve repair procedure (percutaneous or surgical). 7. Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip | 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 Patient over 18 years old Patient with mitral valve prolapse Patient who has received full information about the organization of the research and has signed an informed consent Patient affiliated to or beneficiary of a social security insurance Patient who has completed a prior clinical examination adapted to the research and who does not show any contraindication to the planned examinations Stage of the disease: Patients with MVP with severe mitral regurgitation with a surgical indication as defined by current recommendations will not be included in the study Presence of severe rhythm disorders requiring the implantation of a defibrillator (cardiorespiratory arrest recovered, sudden death recovered, etc.) Performance of an injected MRI in the month preceding the MRI scheduled during visit n°1 Previously diagnosed cardiopathy that may be responsible for myocardial damage (ventricular remodeling, alteration of left ventricular systolic function, fibrosis, etc.) and that may disrupt the interpretation of results (infarction, amyloidosis, systemic scleroderma, significant aortic valvulopathy, etc.) Contraindication to MRI examination, particularly in the presence of an implantable pacemaker or defibrillator, implanted pump, cochlear implants, neurosurgical clips, intraorbital or encephalic metallic foreign bodies Claustrophobia or morphotype that does not allow MRI to be performed Motor or mental disability Renal impairment that does not allow the injection of Gadolinium-based contrast media (DOTAREM® or equivalent in the study). If there is any doubt as to the patient's renal function, a plasma creatinine determination will be performed for MRI to ensure the absence of renal failure Hypersensitivity to gadoteric acid, meglumine, or any gadolinium-containing drug Women of childbearing age who do not have effective contraception | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, HER2-negative Breast Cancer HER2-positive Breast Cancer Recurrent Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Histologically confirmed adenocarcinoma of the female breast which is inoperable, recurrent or metastatic HER-2/neu status must be known at the time of protocol registration; HER-2/neu assessment will be based on FISH analysis of either the primary tumor or a metastatic site; a scoring of 0 or 1+ by immunohistochemistry (IHC) is considered negative; 2+ is considered negative unless confirmed by FISH positivity, in which case it should be considered positive; 3+ by IHC is considered positive; for centers using FISH only, a positive FISH assay by itself is sufficient to determine HER-2 positivity Patients with the following prior therapy are eligible Patients with 0-1 prior chemotherapy regimens for metastatic or locally advanced breast cancer, with the following exception: no prior taxane for metastatic/locally advanced breast cancer Patients with 0-1 prior chemotherapy regimens in the adjuvant setting; if adjuvant regimen included a taxane, patient must have been disease free for at least 12 months from completion of adjuvant therapy until relapse Patients must be > 2 weeks from prior surgery, other than simple biopsy or placement of venous access device; patients must be > 4 weeks from prior chemotherapy; patients must be >6 weeks from nitrosoureas, melphalan, or mitomycin Patients must be > 4 weeks from prior hormonal therapy unless tumor measurements document clear progression while on treatment; if progression is documented and toxicity from hormonal regimen has resolved, patients may be placed on study > 1 week from prior hormonal therapy Prior Herceptin therapy is not allowed Patients with central nervous system metastases are eligible only if the patient has completed cranial irradiation at least 6 months prior, is currently asymptomatic, and is not currently receiving corticosteroids for this condition; patients with leptomeningeal carcinoma (carcinomatous meningitis) are not eligible Any mass reproducibly measurable in two perpendicular dimensions, examples | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Lymphoma Histologically or cytologically proven HIV-associated B cell non-Hodgkin's lymphoma, including Diffuse large B cell lymphoma Intermediate grade diffuse large cell lymphoma High grade large cell immunoblastic lymphoma Burkitt's lymphoma High grade B cell lymphoma, Burkitt's like (small noncleaved lymphoma) No primary CNS lymphoma (parenchymal brain or spinal cord tumor) Evaluable disease HIV documentation may be serologic (ELISA or western blot), culture, or quantitative PCR or bDNA assay Tumors must be CD20 positive (greater than 50% cells express CD20) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology Age: Over 18 | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Distal Urethral Cancer Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter Proximal Urethral Cancer Recurrent Bladder Cancer Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter Recurrent Urethral Cancer Stage IV Bladder Cancer Transitional Cell Carcinoma of the Bladder Urethral Cancer Associated With Invasive Bladder Cancer Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, urethra, ureter, or renal pelvis No pure adenocarcinomas, pure squamous cell carcinomas, small cell carcinoma, or only small foci of TCC (less than 10% of tumor specimen) Locally advanced (T4b) TCC of the bladder Metastatic (N2 or N3 or M1)TCC of the urothelium HER2 expression (3+) as determined by immunohistochemistry or gene amplification by fluorescent in situ hybridization Must not be a candidate for potentially curative surgery or radiotherapy Measurable disease At least 1 unidimensionally measurable lesion of at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following lesions are considered nonmeasurable Bone lesions | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-100.0, Cardiovascular Diseases Heart Diseases Hypertension | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-70.0, Lymphoma One of the following histologically confirmed diagnoses High grade non-Hodgkin's lymphoma Immunoblastic or small noncleaved cell lymphoma (Burkitt's or non-Burkitt's) in complete or partial remission after initial therapy Localized (stage I or Zeigler stage A) small noncleaved (Burkitt's or non-Burkitt's) after relapse or incomplete response to initial therapy Lymphoblastic lymphoma in second or greater complete or partial response High risk lymphoblastic lymphoma in first complete remission or after initial therapy (high risk factors stage IV disease, LDH greater than 2 times normal, and 2 or more extranodal sites) Intermediate grade non-Hodgkin's lymphoma Diffuse large cell lymphoma Diffuse mixed cell lymphoma Diffuse small cleaved cell lymphoma | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Recurrent Bladder Cancer No concurrent radiotherapy No prior angioplasty No concurrent chemotherapy No concurrent oral or IV corticosteroids for more than 2 consecutive weeks or orally inhaled corticosteroids for more than 4 consecutive weeks during any 6 month period of the study Chronic nasally inhaled steroids allowed provided patient agrees to use mometasone or, in countries where mometasone is not available, fluticasone No prior coronary bypass surgery At least 30 days since prior investigational medication No other prior malignancy within the past 5 years except No prior pelvic radiotherapy Histologically proven superficial transitional cell carcinoma of the bladder at high risk for recurrence, meeting 1 of the following staging | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-21.0, Childhood Chronic Myelogenous Leukemia Chronic Myelogenous Leukemia, BCR-ABL1 Positive Chronic Phase Chronic Myelogenous Leukemia Diagnosis of Philadelphia chromosome positive (Ph+) chronic phase chronic myelogenous leukemia (CML) Stratum I (closed to accrual as of 12/05/03) CML in first chronic phase with resistance to interferon alfa (IFN-A) therapy defined as one of the following WBC count at least 20,000/mm^3 after at least 3 months of treatment with an IFN-A-containing regimen Rising WBC count (at least 100% increase to a level of at least 20,000/mm^3) by two samples at least two weeks apart while receiving treatment with an IFN-A-containing regimen At least 66% Ph+ cells in bone marrow after 1 year of IFN-A therapy At least 30% increase in Ph+ cells in bone marrow after IFN-A-induced cytogenetic response while continuing to receive IFN-A therapy Intolerance to interferon therapy defined as more than two grade 2 toxic effects or any grade 3 toxic effect related to interferon therapy, except grade 3 fever, that is persistent beyond the first 28-day course of therapy and unresponsive to standard supportive care interventions Stratum II (closed to accrual as of 7/29/05): CML recurring after stem cell transplantation or in second or subsequent chronic phase No molecular relapse (only evidence is detection of bcr-abl rearrangement with normal bone marrow and blood morphology and normal standard cytogenetic analysis) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 0.0-17.0, Bacterial Infections Other specific inclusion/ may apply. In order to determine further examination by the investigator is necessary Hospitalized/chronic care pediatric patients (birth through 17 years) Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections Requires a minimum of 3 days of IV medication Patients with mixed infections due to VRE & gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required Potentially effective concomitant antibiotic A high surgical cure rate Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days hours of antibiotic treatment within 48 hours of study entry (unless pre-approved) Having an infected device that could not be removed | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections SCI UTI | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Ileus Neoplasms Previous surgical cancer treatment with ileostomy/colostomy, now scheduled for closure Hospital admission must be same day as surgery Incapacitating disease Concurrent herbal or laxative use Use of Heparin or Coumadin Upper or lower extremity deformities Chronic constipation prior to cancer diagnosis History of cerebrovascular accident or spinal cord injury Chronic pain that has been treated with any form of major opioid or weak opioids (=/> 30mg/24 hours) Pacemaker or metal implants Concurrent alternative medicine/herbal use | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 19.0-999.0, Urinary Tract Infection At least two UTIs in the year prior to study entry Willing to use acceptable methods of contraception Willing to refrain from consuming other forms of cranberry supplementation Current UTI Allergy to cranberry-containing products Active urinary stone disease Insulin-dependent diabetes Immunosuppressive disease Current corticosteroid use Intermittent or indwelling catheterization Pregnancy | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Stomatitis Male or female patients ages > 18 yrs Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation Patients with Karnofsky performance scores > or = 70% Informed consent for participation in study Patients who weigh < 33 kg Premenopausal female patients who are pregnant, lactating or are likely to become pregnant Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C Patients with known hypersensitivity to recombinant protein therapeutics Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days Patients who have untreated symptomatic dental infection Patients with a history of sensitivity or allergy to E. coli-derived products Patients with WHO Grade 3 or 4 oral mucositis (OM) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Nodal Marginal Zone B-cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Small Lymphocytic Lymphoma Refractory Multiple Myeloma Splenic Marginal Zone Lymphoma Stage II Multiple Myeloma Stage III Adult Burkitt Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Mixed Cell Lymphoma Stage III Adult Diffuse Small Cleaved Cell Lymphoma Stage III Adult Immunoblastic Large Cell Lymphoma Stage III Adult Lymphoblastic Lymphoma Stage III Grade 1 Follicular Lymphoma Stage III Grade 2 Follicular Lymphoma Stage III Grade 3 Follicular Lymphoma Stage III Mantle Cell Lymphoma Stage III Marginal Zone Lymphoma Stage III Multiple Myeloma Stage III Small Lymphocytic Lymphoma Stage IV Adult Burkitt Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Mixed Cell Lymphoma Stage IV Adult Diffuse Small Cleaved Cell Lymphoma Stage IV Adult Immunoblastic Large Cell Lymphoma Stage IV Adult Lymphoblastic Lymphoma Stage IV Grade 1 Follicular Lymphoma Stage IV Grade 2 Follicular Lymphoma Stage IV Grade 3 Follicular Lymphoma Stage IV Mantle Cell Lymphoma Stage IV Marginal Zone Lymphoma Stage IV Small Lymphocytic Lymphoma Unspecified Adult Solid Tumor, Protocol Specific Waldenström Macroglobulinemia Patients must have cytologically or histologically confirmed tumors that are metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; Patients with solid tumors, multiple myeloma, or non-Hodgkin's lymphoma are eligible Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; Lesions that are considered non-measurable the following Bone lesions Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed by imaging techniques Cystic lesions ≥ 4 weeks since major surgery | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infection Bacteriuria Urethral catheter in situ for at least 3 days (72h) Pregnancy Impaired renal or hepatic function (serum creatinine > 150 mmol/l, serum transaminases > 75 IU/l) Fever Symptomatic urinary tract infection Antibiotic use ≤ 48 hours before urinary catheter removal Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin Urologic pathology | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Hepatitis B, Chronic Hepatitis C, Chronic Male and female patients >= 18 years of age will be recruited Patients with dual chronic hepatitis C and B must be positive for both anti-HCV and HBsAg for more than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS HCV Test version 2.0) Patients must not be positive for HBeAg Patients with monoinfected chronic hepatitis C must be positive for anti-HCV for more than 6 months and HCV RNA quantifiable at 600 IU/mL (by the COBAS HCV Test version 2.0). Patients must not be positive for HBsAg. All patients must Be treatment naïve for the hepatitis disease or have had treatment failure to previous interferon monotherapy or treatment failure to previous lamivudine therapy Present with elevated serum ALT levels at least 1.5 times the upper limit of normal, documented on two occasions (at least one month apart), within six months prior to enrollment Present with liver biopsy findings compatible with the diagnosis of chronic liver disease (the liver biopsy needs to be taken within 52 weeks prior to the first dose of study drug) Have adequate liver reserve (defined as equal to or better than Child-Pugh Class A) Present with WBC 3500/mm3, ANC 1500/mm3, and platelets 90,000/mm3 Be drug addicts or have any history or histological evidence of alcohol abuse, or currently receive prescriptions that may cause hepatotoxicity Present with hemoglobin <12.0 gm/dl for females and <13.0 gm/dl for males Signs or symptoms of hepatocellular carcinoma Any investigational drug ? 6 weeks prior to the first dose of study drug Have renal insufficiency (serum creatinine concentration >1.5 x upper limit of normal at screening; upper limit depending on lab at each site) Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated Have serological evidence of autoimmune chronic liver disease (e.g. antinuclear antibody titers > 1:320, and/or smooth muscle antibody titers > 1:160) History of major organ transplantation with an existing functional graft History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study Thyroid dysfunction not adequately controlled (TSH and T4 levels out of normal range) | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 5.0-999.0, Hemophilia A Age >= 5 years The subject has severe or moderately severe hemophilia A defined by a baseline factor VIII level <= 2% of normal documented at screening or historically (e.g., at hemophilia diagnosis) Subjects may enroll regardless of their serologic status for human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV) The subject requires a surgical, dental or other invasive procedure--either elective or emergency The subject has a history of at least 150 exposure days for all other factor VIII products (as estimated by the study site investigator) prior to study entry The subject has a life expectancy of at least 28 days from the day of surgery The subject has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter BioScience The subject has a detectable inhibitor to factor VIII in the local hemostasis laboratory at the investigative site at the time of enrollment The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but demonstrated expected clinical responses to conventional doses of factor VIII therapy, the subject may enroll The subject has known hypersensitivity to Recombinate The subject is currently participating in another investigational drug study, or has participated in any clinical trial involving an investigational drug within 30 days of study entry The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura, disseminated intravascular coagulation) The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 40.0-95.0, COPD Subject is able to ambulate. Defined as a 6MWD greater than 110 meters Subject is diagnosed with COPD years-old and older Currently or previously smoking with a smoking history of at least 10 pack-years Forced expiratory volume on one second (FEV1) after the use of a bronchodilator between 25 an 70% of the predicted value, and FEV1 to forced vital capacity ratio less than 70% No previous diagnosis of asthma, left heart congestive heart failure (either radiographic evidence of pulmonary congestion, echocardiographic or ventriculographic evidence of a reduced ventricular ejection fraction), terminal disease, dementia or uncontrolled psychiatric illness Never participated to a respiratory rehabilitation program and not staying or planning to stay in a long term care facility Subject understands and is able to read and write French or English MRC dyspnea scale of at least 2 The need for supplemental oxygen at rest or during exercise will not be an criterion | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-70.0, Chronic Hepatitis C All eligible adult patients with compensated liver disease due to chronic infection with HCV and genotype 1 infection who are treatment naïve will be enrolled into the study All racial and ethnic groups will be recruited into this study Males and females: age > 18 years Chronic hepatitis C: history of serum positive for HCV antibody (anti-HCV) and HCV RNA. Patients should have evidence of chronic hepatitis with a minimum fibrosis score of 1 on liver biopsy done within 6 months of enrollment Insulin resistance based on HOMA index value (HOMA-IR) of > 2.0 during screening. HOMA-IR is a well recognized and validated index of insulin resistance in both non-diabetic and diabetic populations and has been shown to have a good correlation with 'clamp' techniques that are intensive. HOMA is also used routinely to assess longitudinal changes including assessment of the effects of treatment. In general, a HOMA-IR value of > 1.5 is considered abnormal based on repeat testing measurements performed by both HOMA assessment and by euglycemic clamp technique and is considered representative of decreased insulin sensitivity. Although insulin secretion is pulsatile, the correlation between HOMA computed from repeat sampling (using a mean of three samples taken at 5-minute intervals to compute HOMA) and the value obtained from a single basal sample to determine insulin sensitivity has been shown to be near perfect even in patients with type 2 diabetes (r = 0.99, p < 0.0001). The investigators will use a HOMA-IR value of > 2.0 as part of the in this study Able and willing to provide written informed consent Hepatitis C patients who underwent previous therapy for their liver disease Genotype other than type 1 Histological evidence of cirrhosis or confirmed hepatocellular carcinoma (HCC) Patients with cirrhosis and decompensated liver disease and any patient, in whom a liver biopsy is contraindicated, will be excluded Evidence of other causes of chronic liver disease Diabetes mellitus New York Heart Association (NYHA) functional classification for cardiac disease: class III and IV patients Human immunodeficiency virus (HIV) antibody positive Patients with solid organ transplants Pregnancy or breast feeding | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 16.0-999.0, Urinary Infections Hospitalized patients over 16 years of age with complicated urinary infection produced by bacteria that are suspected to be susceptible to treatment with Piperacillin-tazobactam Patients known, or thought to be hypersensitivity to beta-lactams Patients with an uncomplicated urinary tract infection | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Pyelonephritis Positive dipstick test for leukocyte esterase AND/OR at least 5 white blood cells per centrifuged urine sediment AND/OR at least 10 white blood cells per microliter of uncentrifuged urine outpatient or inpatient (in hospital, nursing home, or other extended-care facility) clinical diagnosis of either complicated urinary tract infection or acute pyelonephritis Allergy or serious adverse reaction to levofloxacin, ciprofloxacin, or other fluoroquinolone urinary tract surgery or lithotripsy (treatment for kidney stones) within 7 days before study entry a second coexisting bacterial infection that requires systemic antibiotics need for a second antibiotic to treat the urinary tract infection obstruction of the urinary tract prostate infection | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Pyelonephritis Diagnosis of complicated lower urinary tract infection or pyelonephritis Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control History of moderate or severe hypersensitivity reactions to antibiotic medications | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 60.0-85.0, Idiopathic Normal Pressure Hydrocephalus Patients who had at least one more points of the triad (gait disturbance, cognitive impairment, and urinary incontinence) in Japan NPH grading scale revised, and had disproportionate ventriculomegaly (Evans index >0.3) with closing of the CSF space at high convexity on MRI. These patients must be diagnosed clinically other causative disorders, and ventricular dilatation due to disturbance of the cerebrospinal fluid (CSF) circulation. Be able to give informed consent Cannot have an MRI scan 2) Has a problem with bleeding tendency and other serological examination. (liver enzyme and renal dysfunction, blood coagulopathy, and etc.) 3) Is unable to understand the risks of the testing and surgical therapy. 4) is tolerable for one year follow up after shunting operation | 0 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Pyelonephritis Diagnosis of complicated lower urinary tract infection or pyelonephritis Women who are pregnant, nursing or of child-bearing potential and not using a medically accepted, effective method of birth control History of moderate or severe hypersensitivity reactions to antibiotic medications | 2 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Bacteriuria Urologic Diseases Pyelonephritis Neurogenic Bladder Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities capable of taking medication by mouth previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle complete obstruction of any part of the urinary tract inflammation of the prostate gland previous allergic or serious adverse reaction to similar antibiotics pregnant or nursing females, or those lacking adequate contraception | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-999.0, Urinary Tract Infections Bacterial Infections Bacteriuria Urologic Diseases Diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities capable of taking medication by mouth previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection Patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle complete obstruction of any part of the urinary tract previous allergic or serious adverse reaction to similar antibiotics inflammation of the prostate gland pregnant or nursing females, or those lacking adequate contraception | 1 |
62 yo male with hx of CVA, neurogenic bladder with indwelling suprapubic catheter with multiple prior admissions for UTIs, altered mental status, and urosepsis presents to the hospital in urosepsis now resolved after treatment with vanc/meropenem. Per CT there is a non-obstructing stone in the L ureter, no evidence of urethral strictures. Significant leaking around suprapubic cath site. Started on ditropan changed over to detrol. Urologist not concerned with leaking and will f/u with pt next week. s/p CVA Neurogenic bladder s/p suprapubic cath Recurrent UTIs with Klebsiella/Pseudomonas Non-hodgkins Marginal Zone Lymphoma of the left orbit Dx in 03 (s/p R-CHOP x 6 cycles) Bells Palsy BPH Hypertension Partial Bowel obstruction s/p colostomy Hepatitis C Cryoglobulinemia SLE with transverse myelitis, anti-dsDNA Ab+ Insulin Dependant Diabetic Fungal Esophagitis Stage IV? Urinary Tract Infections-pseudomonas & enterococcus | eligible ages (years): 18.0-75.0, Recurrent Urinary Tract Infections in Women Three or more urinary tract infections in the previous year Neurogenic bladder Interstitial cystitis Urinary diversion Kidney stones Indwelling catheter | 1 |
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