A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSierra Valve LLC
About this trial
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%
Trial design
Treatments tested in this trial
- GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov