GeminiOne TEER System for Severe Mitral Regurgitation
This study is testing the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for people with severe, symptomatic mitral regurgitation (MR), a condition where the heart's mitral valve doesn't close properly, causing blood to leak backward. The GeminiOne TEER System uses a clip to help the valve close better. Researchers want to confirm how safe and effective this device is. You might be able to join if you are 18 or older and have severe MR. For people with primary MR, you must be considered high-risk for surgery. For secondary MR, you must have tried other treatments without success. The study will look at safety by checking for major problems within 30 days, and effectiveness by seeing if the procedure is successful right away. The study is currently enrolling up to 15 participants.
- Study design
- This is a multi-center study where all 15 participants will receive the GeminiOne TEER System. It is not randomized, meaning there is no comparison group.
- What's involved
- You will receive the GeminiOne TEER System. You will be followed for 60 months (5 years) after the device is implanted.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 60 months (5 years) after the device is implanted.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Safety: Absence of device or procedure related major adverse events at 30 days30 days
MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure.
- Effectiveness: Acute procedural success (APS)30 days
APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure.