RecruitingNot Applicable

A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

United States15 participantsStarted 2026-03-26

Plain-language summary

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age 18 years or older(≥ 18 years)
✓. 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.
✓. Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
✓. Feasible transseptal catheterization and femoral vein access.
✓. Written informed consent from subject or legal representative.

Exclusion criteria

✕. History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
✕. Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
✕. Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
✕. Left ventricular ejection fraction (LVEF)\< 20%
✕. Left ventricular end-systolic diameter(LVESD)\> 60mm
✕. Mobile leaflet length less than 10mm
✕. Mitral valve effective orifice area (EOA) \< 3.5cm or a high risk of mitral stenosis developing after device implantation, as judged by site investigators, core lab, and eligibility committee.
✕. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.

What they're measuring

Safety: Absence of device or procedure related major adverse events at 30 days

Timeframe: 30 days

Effectiveness: Acute procedural success (APS)

Timeframe: 30 days

Trial details

NCT IDNCT07086534

SponsorSierra Valve LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-30

Contact for this trial

Jianfong Tan

+19495397412 Jianfong@Sierravalve.com

View on ClinicalTrials.gov More Mitral Regurgitation trials