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

NCT07086534 | Recruiting FDA Device

• 1 other identifier: EFSGemini1US
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• 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

Other Outcomes (2)

• Technical success

  at exit from procedure room

• Device success

  12 months

Study Arms (1)

Subjects receiving the treatment of GeminiOne TEER system

EXPERIMENTAL

Device: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System

Interventions

GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System DEVICE

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.

Subjects receiving the treatment of GeminiOne TEER system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older(≥ 18 years)
• 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.
• Anatomically suitable for TEER with GeminiOne device as confirmed by site investigators, core lab, and eligibility committee.
• Feasible transseptal catheterization and femoral vein access.
• Written informed consent from subject or legal representative.

You may not qualify if:

• History of heart transplantation, prior mitral valve replacement surgery, or transcatheter mitral valve procedure.
• Leaflet anatomy that precludes optimal positioning of the GeminiOne device, as determined by site investigators, core lab, and eligibility committee.
• Evidence of severe calcification or significant cleft in the grasping area of the mitral valve leaflets.
• Left ventricular ejection fraction (LVEF)\< 20%
• Left ventricular end-systolic diameter(LVESD)\> 60mm
• Mobile leaflet length less than 10mm
• 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.
• Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
• Presence of severe non-mitral valve disease requiring intervention.
• Severe pulmonary artery hypertension(sPAP \>70mmHg).
• Severe right ventricular dysfunction. 12, Active endocarditis or history of mitral valve endocarditis. Active rheumatic heart disease or leaflets severely degenerated from rheumatic disease.
• \. Severe untreated coronary artery stenosis requiring revascularization or other cardiovascular disease requiring surgery.
• Patents with extreme frailty. 15.Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure besides dilated cardiomyopathy.
• \. Severe renal insufficiency with estimated glomerular filtration rate (eGFR) \< 25 mL/min.
• \. 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.

Sponsors & Collaborators

• Sierra Valve LLC: lead

Study Sites (1)

Los Robles Regional Medical Centre

Thousand Oaks, California, 91360, United States

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Jianfong Tan

CONTACT

+19495397412; Jianfong@Sierravalve.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 25, 2025
• Study Start: March 26, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 31, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

US (1)