Actively Recruiting
A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).
Led by Sierra Valve LLC · Updated on 2026-04-24
15
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for adults with severe, symptomatic mitral regurgitation (MR). This multi-center, non-randomized clinical trial aims to confirm the safety and effectiveness of the device in patients who are at high risk for surgical intervention or have not responded to other therapies. The study is sponsored by Sierra Valve LLC and involves participants from centers in the United States, Canada, and Europe. Participants will receive the investigational GeminiOne TEER System, which includes a clip implant made from specialized alloys and a delivery system designed for left atrial placement through transfemoral trans-septal access. Up to 15 subjects will be treated initially, and the study will last about 72 months with a 12-month enrollment period. After implantation, participants will be followed for 60 months to monitor outcomes. During the study, participants will undergo assessments including echocardiography, functional status evaluation, and quality of life questionnaires at 30 days, 12 months, and annually thereafter. Researchers will track major adverse events, mortality, stroke, rehospitalizations, and changes in heart function and symptoms. Safety and procedural success will be monitored closely during the first 30 days post-implant, with continued evaluation throughout the follow-up period.
CONDITIONS
Brief Title
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (≥ 18 years)
- Severe mitral regurgitation (Grade III or greater) confirmed by echocardiography
- For primary MR: high or prohibitive surgical risk as determined by heart team
- For secondary MR: failed optimal guideline-directed medical therapy for at least one month, including coronary revascularization and cardiac resynchronization therapy if indicated
- Suitable anatomy for GeminiOne TEER device confirmed by investigators and eligibility committee
- Feasible transseptal catheterization and femoral vein access
- Provided written informed consent
You will not qualify if you...
- History of heart transplantation, prior mitral valve replacement surgery, or prior transcatheter mitral valve procedure
- Leaflet anatomy unsuitable for optimal GeminiOne device positioning
- Severe calcification or significant cleft in mitral valve leaflets
- Left ventricular ejection fraction (LVEF) less than 20%
- Left ventricular end-systolic diameter (LVESD) greater than 60mm
- Mobile leaflet length less than 10mm
- Mitral valve effective orifice area (EOA) less than 3.5cm² or high risk of mitral stenosis after device implantation
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Severe non-mitral valve disease requiring intervention
- Severe pulmonary artery hypertension (sPAP >70mmHg)
- Severe right ventricular dysfunction
- Active or history of mitral valve endocarditis or rheumatic heart disease
- Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease needing surgery
- Extreme frailty
- Hypertrophic, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure besides dilated cardiomyopathy
- Severe renal insufficiency (eGFR < 25 mL/min)
- Blood disorders including granulocytopenia, acute anemia, thrombocytopenia, severe coagulopathy, or anticoagulant contraindications
- Acute myocardial infarction within past 4 weeks
- Stroke within prior 90 days
- Percutaneous cardiac intervention, carotid surgery, or cardiac surgery within 30 days prior
- Severe symptomatic carotid artery stenosis exceeding 70%
- Medical or psychiatric conditions interfering with trial evaluation
- Life expectancy less than 12 months
- Participation in another investigational study within past 1 month
- Potential non-compliance
- Anatomic characteristics or devices precluding transseptal approach
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants receive the investigational GeminiOne TEER System device implanted via a transcatheter procedure to treat severe symptomatic mitral regurgitation.
1 implantation visit (in-person)
Duration - 60 months post-implantation
Participants are monitored for safety, device performance, and clinical outcomes following device implantation.
Follow-up visits at 30 days, 12 months, and annually thereafter up to 60 months
Trial Site Locations
Total: 1 location
1
Los Robles Regional Medical Centre
Thousand Oaks, California, United States, 91360
Actively Recruiting
Research Team
J
Jianfong Tan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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