A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

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

To confirm the effectiveness and safety of the GeminiOne Transcatheter Mitral Valve Repair System for the treatment of severe, symptomatic mitral regurgitation.

Study Overview

• Status: Recruiting
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System

Detailed Description

This study is a prospective, multi-center, non-randomized clinical trial. All enrolled subjects will receive the investigational GeminiOne TEER System in a single-arm design. The trial will be conducted at up to seven clinical centers located in the United States, Canada, and Europe.

The GeminiOne TEER System is intended for use in adult patients with severe symptomatic mitral regurgitation (MR) who have suitable anatomy for both device implantation and transfemoral trans-septal access for left atrial delivery.

Key Inclusion Criteria:

Primary MR: Patients must be deemed high-risk for surgical intervention by the site's heart team.

Secondary MR: Patients must have failed to respond to optimal guideline-directed medical therapy (GDMT) for at least one month, and must also have received appropriate coronary revascularization and cardiac resynchronization therapy (CRT), if indicated.

Initially, up to 15 subjects will be treated. The total duration of the study is expected to be approximately 72 months. The enrollment period will span approximately 12 months. Subjects who receive the investigational device will be followed for 60 months post-implantation.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianfong Tan; Phone Number: +19495397412; Email: Jianfong@Sierravalve.com

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91360
      • Recruiting
      • Los Robles Regional Medical Centre
      • Contact: Saibal Kar; Email: Saibal.Kar@hcahealthcare.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving the treatment of GeminiOne TEER system	Device: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System; The GeminiOne TEER System consists of a TEER clip implant, transcatheter delivery system and a guide sheath. The clip is made of cobalt-chromium-nickel alloy with a nickel-titanium alloy gripper, covered with a braided mesh of polyethylene terephthalate (PET) materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Absence of device or procedure related major adverse events at 30 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.	30 days
Effectiveness: Acute procedural success (APS)	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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality and stroke		30 days, 12 months and annually thereafter
Cardiovascular mortality		30 days, 12 months and annually thereafter
Rate of cardiovascular rehospitalization		30 days, 12 months and annually thereafter
Mitral valve surgery or re-intervention		30 days, 12 months and annually thereafter
Change in NYHA functional class		30 days, 12 months and annually thereafter
Mitral valve hemodynamics	Includes degree of residual mitral regurgitation and mean mitral valve gradient.	30 days, 12 months and annually thereafter
Change in 6-Minute Walk Test (6MWT) performance		30 days, 12 months and annually thereafter
Change in Quality of Life as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)		30 days, 12 months and annually thereafter
Incidence of serious adverse events (SAEs)	A SAE is defined as any adverse event that meets one or more of the following criteria:<; Death; life-threatening or results in serious illness or injury; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in a congenital anomaly/birth defect, fetal death, or fetal distress; Requires medical or surgical intervention to prevent permanent impairment to a body structure or body function; considered an important medical event that may jeopardize the patient or subject and/or may require intervention to prevent one of the outcomes listed above, based on appropriate medical judgment.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Must meet all of the following criteria: No procedural mortality; Successful access, delivery, and retrieval of the device delivery system; No emergency surgery or reintervention related to the device or access procedure	at exit from procedure room
Device success	Must meet all of the following criteria:<; No procedural mortality; Proper delivery and deployment of the device; No unplanned surgical or interventional procedures related to the device; No specific device-related technical failure or complication; Improvement of mitral regurgitation without significant stenosis (MR ≤ 2+), and without associated hemolysis or thrombogenesis	12 months

Collaborators and Investigators

• Sponsor: Sierra Valve LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2031

Study Registration Dates

• First Submitted: July 15, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Mitral Valve Insufficiency; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: EFSGemini1US

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes