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RECRUITINGNA

Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

NCT07055919•Xiamen Cardiovascular Hospital, Xiamen University

View on ClinicalTrials.gov

Summary

This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years, regardless of gender.
•2. Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
•For degenerative mitral regurgitation (DMR):
•-Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.
•For functional mitral regurgitation (FMR):
•* Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
•* ≥1 hospitalization for heart failure within the past 12 months and/or BNP \>150 pg/mL or NT-proBNP \>600 pg/mL.
•* Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
•3. Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
•4. Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.

Exclusion Criteria

•1. Rheumatic mitral valve disease.
•2. Uncorrected active infection.
•3. Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
•4. Intracardiac mass, thrombus, or vegetation on echocardiography.
•5. Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure \>70 mmHg).
•6. Severe left heart dysfunction (LVEF \<20%).
•7. Acute myocardial infarction (AMI) within 30 days prior to the procedure.
•8. Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
•9. Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
•10. Prior surgical or transcatheter mitral valve repair/replacement.
+10 more criteria

Locations (1)

Structural Heart Disease Unit, Xiamen Cardiovacular Hospital

Xiamen, Fujian, China

Key Dates

Start Date

March 22, 2025

Primary Completion Date

March 22, 2026

Completion Date

April 22, 2026

Last Updated

July 9, 2025

Enrollment

112

ESTIMATED participants

Conditions

Mitral RMitral Regurgitation

Interventions

Structural Heart Surgery Assist System

DEVICE

Manual MitraClip G4

DEVICE

Contacts

Xiang Chen, Dr

CONTACT

18033997788 seanchenx@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

Inclusion Criteria

Exclusion Criteria

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