AMEND TS Early Feasibility Study
Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments.
| Condition(s) | Symptomatic Functional MR 3 or Greater |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Valcare Medical AMEND Trans-Septal System is a mitral valve repair annuloplasty ring implanted in a trans-catheter method intended for correction of mitral regurgitation. It is designed to be used as standalone therapy or in combination with other repair treatments. |
| Who can participate | Inclusion Criteria: 1. Patient age \>21 2. The patient will benefit from isolated mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures such as coronary artery bypass or another valve reconstruction or replacement 3. Symptomatic functional MR≥3+ 4. NYHA functional capacity ≥2 5. LV Ejection Fraction \> 30%, LVEDD \< 68 mm 6. The subject meets the anatomical eligibility criteria for available implant size(s) 7. The subject is at high risk for mitral valve surgery as assessed by the center's heart team for mitral procedures. 8. The subject has been stable and on a stable pharmacological regimen for heart failure for at least 1 month prior to inclusion 9. Femoral vein access and transseptal device access is determined to be feas |
| Ages | 21 Years |
| Sex | All |
| Lead sponsor | Valcare Medical Ltd. |
| Locations | Phoenix, Arizona, United States; La Jolla, California, United States; Atlanta, Georgia, United States; Indianapolis, Indiana, United States; New York, New York, United States; The Bronx, New York, United States (+5 more sites) |
| Start date | 2025-09-11 |
| NCT ID | NCT06951672 |
| Official listing | https://clinicaltrials.gov/study/NCT06951672 |