GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

A Clinical Study of GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for the Treatment of Severe, Symptomatic Mitral Regurgitation (MR).

This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sierra Valve LLC (Industry-sponsored)
• Locations: 1 site (Thousand Oaks, California)
• Trial ID: NCT07086534 on ClinicalTrials.gov

What this trial studies

This is a prospective, multicenter, non-randomized single-arm trial testing the GeminiOne transcatheter edge-to-edge repair (TEER) system in adults with severe symptomatic mitral regurgitation. Up to seven centers in the United States, Canada, and Europe will deliver the device via transfemoral trans-septal left atrial access, with initial enrollment planned for up to 15 subjects and each subject followed for 60 months. Patients with primary MR must be deemed high or prohibitive surgical risk, while patients with secondary MR must have failed guideline-directed medical therapy and, if indicated, coronary revascularization and cardiac resynchronization therapy. The study will collect safety and effectiveness outcomes over an expected total study duration of approximately 72 months.

Who should consider this trial

Good fit: Adults (≥18) with severe (3+ or 4+) symptomatic mitral regurgitation who are anatomically suitable for TEER and either are high/prohibitive surgical risk (primary MR) or have failed optimal medical therapy and indicated revascularization/CRT (secondary MR).

Not a fit: Patients who do not have anatomy suitable for transfemoral trans-septal TEER, who are good candidates for surgical repair/replacement, or who have not completed indicated medical/revascularization/CRT optimization are unlikely to benefit from this device in this study.

Why it matters

Potential benefit: If successful, the device could reduce mitral regurgitation and related symptoms and offer a less invasive treatment option for patients who are poor surgical candidates.

How similar studies have performed: Other TEER systems, such as MitraClip, have shown symptom improvement and reduced hospitalizations in selected high-risk patients, but GeminiOne is a new device being tested for comparable outcomes.

Eligibility criteria

Inclusion Criteria:

1. Age 18 years or older(≥ 18 years)
2. 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.

   For patients with primary mitral regurgitation: Deemed high or prohibitive surgical risk (STS score 8 for valve replacement or \> 6 for valve repair or determined by the site heart team due to documented surgical risk factors) For patients with secondary mitral regurgitation: undergone optimal guideline-directed medical therapy (GDMT) for at least one month as determined by the local heart team; coronary revascularization, and cardiac resynchronization therapy (CRT) if clinically indicated, all of which have proven to be ineffective. Local heart team has determined that mitral valve surgery is not an option.
3. Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
4. Feasible transseptal catheterization and femoral vein access.
5. Written informed consent from subject or legal representative.

Exclusion Criteria:

1. History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
2. Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
3. Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
4. Left ventricular ejection fraction (LVEF)\< 20%
5. Left ventricular end-systolic diameter(LVESD)\> 60mm
6. Mobile leaflet length less than 10mm
7. 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.
8. Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
9. Presence of severe non-mitral valve disease requiring intervention.
10. Severe pulmonary artery hypertension(sPAP \>70mmHg).
11. Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.

13\. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.

14.Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.

16\. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \< 25 mL/min.

17\. Blood cachexia including granulocytopenia(WBC\<3x10\^9/L),acute anemia(HB \<90g/L)thrombocytopenia (PLT \<50x10\^9/L), severe coagulopathy, or contraindications to anticoagulant and antiplatelet therapy.

18\. Evidence of an acute myocardial infarction within the past 4 weeks. 19.Evidence of stroke within the prior 90 days. 20. Any percutaneous cardiac intervention, carotid surgery, or any cardiac surgery within 30 days prior to procedure.

21\. Severe symptomatic carotid artery stenosis exceeding 70% confirmed by imaging.

22\. Subjects with underlying medical or psychiatric conditions that may interfere with trial evaluation (e.g. cancer, infection, severe metabolic disease). Additionally, any case deemed unsuitable for the study by the local heart team.

23.Life expectancy of less than 12 months. 24. Participation in another investigational drug or device study within the past 1 month.

25\. Subjects deemed unlikely to complete the trial due to potential non-compliance, as judged by the investigator.

26\. Any anatomic characteristic or presence of atrial septal occluders, which would preclude the performance of the transseptal approach.

Where this trial is running

Thousand Oaks, California

• Los Robles Regional Medical Centre — Thousand Oaks, California, United States (Recruiting)

Study contacts

• Study coordinator: Jianfong Tan

Conditions Mitral Regurgitation