Moderate-to-severe or severe symptomatic mitral regurgitation
Conditions
Interventions
Multi-center, global, prospective, interventional, pre-market trial Enrolled subjects will be assigned to Transcatheter Mitral Valve Replacement (TMVR) with the Medtronic Intrepid TMVR System
Sponsors
Medtronic Japan Co., Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject has moderate-to-severe or severe symptomatic mitral regurgitation - or subject has moderate symptomatic mitral regurgitation combined with mitral stenosis with the presence of mitral annular calcification (MAC; for the MAC cohort only) 2. Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention 3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits 4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements
Exclusion criteria
Exclusion criteria: Refer Protocol for details. 1. Estimated life expectancy of less than 24 months due to associated non-cardiac comorbid conditions 2. Currently implanted mitral valve 3. Prior transcatheter mitral valve procedure with device currently implanted 4. Anatomic contraindications for Intrepid TMVR System (e.g., annular dimensions, high risk of LVOT obstruction, system access, etc. 5. Anatomically prohibitive mitral annular calcification (MAC) 6. Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment 8. Moderate or greater tricuspid regurgitation with echocardiographic evidence of significantly impaired right ventricular function as assessed by the echo core lab 12. Left ventricular ejection fraction (LVEF) <30% measured by resting transthoracic echocardiogram 14. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure other than dilated ischemic or non-ischemic cardiomyopathy 17. Need for emergent or urgent cardiac or non-cardiac surgery 18. Hemodynamic instability requiring dependency of either inotropic agents or mechanical circulatory support 26. Untreated clinically significant coronary artery disease requiring revascularization 32. End stage renal disease requiring chronic dialysis or creatinine clearance < 45 cc/min within 30 days of the Index Procedure 33. Liver failure (Child-Pugh-C) 34. Any Cancer requiring active treatment or with life expectancy less than 24 months 35. Severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc, continuous home oxygen therapy, or chronic outpatient oral steroid use 36. Frailty assessments 39. Severe dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Cohort: The rate of all-cause mortality, heart failure hospitalization post 30-days, or KCCQ improvement <10 as evaluated at 1 year MAC Cohort: The rate of all-cause mortality or heart failure hospitalization at 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Composite of all-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), prolonged ventilation, deep wound infection, reoperation or reintervention, or greater than or equal to major bleeding at 30 days or at hospital discharge whichever is longer 2. Change in NYHA at 30 days 3. Change in Quality of Life (QoL) at 30 days (SF-12) 4. Change in Quality of Life (QoL) at 3 months as assessed by KCCQ 5. Degree of mitral regurgitation at 1 year as assessed by Echo Core Lab 6. Cardiovascular hospitalization through 1 year | — |
Countries
Japan,North America,Europe
Contacts
Public ContactKoyo Sakaguchi
Clinical Research and Medical Science Clinical Research Division 2
Outcome results
None listed