NCT07086534 A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
| NCT ID | NCT07086534 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sierra Valve LLC |
| Condition | Mitral Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2027-04-30 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older(≥ 18 years) 2. Subject has severe MR (Grade lll or greater per the ASE criteria, which includes severity grades of 3+ and 4+). Severity grades (3+)/ (4+) MR confirmed by core lab review on transthoracic or transesophageal echocardiography. For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or \> 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option. 3. Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core la