A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR. (NCT07086534) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety: Absence of device or procedure related major adverse events at 30 days
. 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.