SATURN Transcatheter Mitral Valve Replacement for Functional Mitral Regurgitation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Regurgitation
- Sponsor
- InnovHeart
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Reduction of mitral regurgitation
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is a prospective, single-arm, multi-center feasibility clinical study of the SATURN TA System for the treatment of NYHA Class ≥ II patients with severe functional mitral regurgitation who are not suitable for surgical treatment following Heart Team assessment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18 years or older.
- •Severe functional mitral regurgitation (≥ Grade 3+).
- •NYHA functional Class ≥ II. If Class IV, patient must be ambulatory.
- •Treatment and compliance with optimal guideline-directed medical therapy (GDMT) for heart failure for at least 30 days.
- •Not a suitable candidate for open mitral valve surgery due to high operative risk, as determined by the Heart Team.
- •Able to complete quality-of-life assessment (KCCQ).
Exclusion Criteria
- •Excessive frailty or comorbid conditions that preclude the anticipated benefit of the valve replacement.
- •Life expectancy \<1 yr due to noncardiac conditions.
- •Active endocarditis.
- •Active systemic infection.
- •Modified Rankin Scale ≥4 disability.
- •Hemodialysis/ chronic renal failure (eGFR \< 35 mL/min/m2).
- •Pulmonary arterial hypertension (fixed PAS \< 60mmHg). 8) COPD on home oxygen.
- •Refuses blood transfusions. 10) Documented bleeding or coagulation conditions (hypo- or hyper-coagulable states).
- •Severe connective tissue disease under chronic immunosuppressive or cortisone therapy.
- •Pregnant/ lactating. Females of childbearing age must be willing to take contraceptives.
Outcomes
Primary Outcomes
Reduction of mitral regurgitation
Time Frame: 30 days
Reduction of mitral regurgitation to ≤1 at 30 days.
Freedom from device-related or procedure-related major adverse events
Time Frame: 30 days
Freedom from device-related or procedure-related major adverse events at 30 days (cardiac death, peri-procedural myocardial infarction, disabling stroke, renal failure requiring dialysis, life threatening bleeding).
Technical success
Time Frame: Day 0
Technical success defined as alive patient at exit from procedure room, with all of the following: * Successful access, delivery and retrieval of the delivery systems. * Development and correct positioning of the bioprosthesis. * Freedom of additional emergency surgery or re-intervention related to the device or access procedure.
Secondary Outcomes
- Patients success(30 days, 1 year, 2 years)
- Freedom from device-related or procedure-related major adverse events(30 days, 1 year, 2 years)
- NYHA functional classification(30 days, 1 year, 2 years)
- KCCQ(30 days, 1 year, 2 years)
- Freedom from all-cause mortality(30 days, 1 year, 2 years)
- Device success(30 days, 1 year, 2 years)
- 6 Minute Hall Walk Test(30 days, 1 year, 2 years)