Heart Valve Diseases, Mitral Disease, Mitral Regurgitation, Mitral Valve Disease, Valve Heart Disease
Conditions
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.
Interventions
DEVICESATURN TA System
SATURN TA TMVR Device implanted
Sponsors
InnovHeart
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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
Exclusion criteria
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device-related or procedure-related major adverse events | 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). |
| Reduction of mitral regurgitation | 30 days | Reduction of mitral regurgitation to ≤1 at 30 days. |
| Technical success | 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
| Measure | Time frame | Description |
|---|---|---|
| Device success | 30 days, 1 year, 2 years | Device success |
| 6 Minute Hall Walk Test | 30 days, 1 year, 2 years | Improvement from baseline in functional status by ≥ 30 meters |
| Freedom from device-related or procedure-related major adverse events | 30 days, 1 year, 2 years | * Freedom from device-related or procedure-related major adverse events throughout long- term follow-up. * Freedom from all-cause mortality |
| NYHA functional classification | 30 days, 1 year, 2 years | Improvement from baseline by ≥ 1 functional classification. |
| KCCQ | 30 days, 1 year, 2 years | Improvement from baseline in Quality of Life by ≥ 10 points. |
| Freedom from all-cause mortality | 30 days, 1 year, 2 years | Freedom from all-cause mortality |
| Patients success | 30 days, 1 year, 2 years | Patients success |
Countries
Denmark, Hungary, Lithuania
Outcome results
None listed