Actively Recruiting
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
Led by Sierra Valve LLC · Updated on 2026-04-24
15
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.
CONDITIONS
Official 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 determined by the site heart team
- For secondary MR: failed optimal guideline-directed medical therapy for at least one month, with appropriate coronary revascularization and cardiac resynchronization therapy if indicated
- Anatomically suitable for GeminiOne TEER device as confirmed by investigators and eligibility committee
- Feasible transseptal catheterization and femoral vein access
- Written informed consent from the subject or legal representative
You will not qualify if you...
- History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure
- Leaflet anatomy preventing optimal device positioning as determined by investigators and eligibility committee
- 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 60 mm
- Mobile leaflet length less than 10 mm
- Mitral valve effective orifice area (EOA) less than 3.5 cm or high risk of mitral stenosis after device implantation
- Presence of intracardiac mass, thrombus, or vegetation on echocardiography
- Severe non-mitral valve disease requiring intervention
- Severe pulmonary artery hypertension (sPAP > 70 mmHg)
- Severe right ventricular dysfunction
- Active or history of mitral valve endocarditis or active rheumatic heart disease with severe leaflet degeneration
- Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery
- Extreme frailty
- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart diseases causing heart failure besides dilated cardiomyopathy
- Severe renal insufficiency with estimated glomerular filtration rate (eGFR) less than 25 mL/min
- Blood cachexia including granulocytopenia, acute anemia, thrombocytopenia, severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy
- Acute myocardial infarction within the past 4 weeks
- Stroke within the prior 90 days
- Any percutaneous cardiac intervention, carotid surgery, or cardiac surgery within 30 days prior to procedure
- Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging
- Underlying medical or psychiatric conditions interfering with trial evaluation (e.g., cancer, infection, severe metabolic disease)
- Life expectancy less than 12 months
- Participation in another investigational drug or device study within the past 1 month
- Deemed unlikely to complete the trial due to potential non-compliance
- Anatomic characteristics or presence of atrial septal occluders precluding transseptal approach
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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