Using a surgical assist system to help fix leaking mitral valves with a MitraClip-style procedure

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).

This trial will test whether adding a Structural Heart Surgery Assist System to transcatheter edge-to-edge repair (TEER) helps adults with moderate-to-severe or worse mitral regurgitation get equally safe and effective results compared with standard manual TEER.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University (Academic / other)
• Locations: 1 site (Xiamen, Fujian)
• Trial ID: NCT07055919 on ClinicalTrials.gov

What this trial studies

This is a prospective, stratified, randomized controlled non-inferiority trial comparing a Structural Heart Surgery Assist System to standard manual TEER (for example, MitraClip G4) in patients with degenerative or functional mitral regurgitation of grade 3+ or greater. Eligible adults will be randomized to either device-assisted TEER or conventional manual TEER and followed for safety and efficacy outcomes. The trial specifically enrolls patients with DMR who are high surgical risk or who decline surgery, and patients with FMR who remain symptomatic despite guideline-directed therapy. Primary comparisons focus on procedural safety and mitral regurgitation reduction, using standardized echocardiographic and clinical endpoints.

Who should consider this trial

Good fit: Adults aged 18 or older with symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) who are scheduled for TEER—including degenerative MR patients at high surgical risk or who decline surgery and functional MR patients with persistent symptoms despite guideline-directed therapy—are ideal candidates.

Not a fit: Patients with less-than-moderate mitral regurgitation, those who are not candidates for TEER, or those who are appropriate surgical repair candidates are unlikely to benefit from this device-focused comparison.

Why it matters

Potential benefit: If successful, the assist system could make TEER procedures more consistent and potentially safer, reducing operator dependence and improving outcomes for patients with severe MR.

How similar studies have performed: Manual TEER with devices like MitraClip is well established, and early work on assistive and robotic tools for structural heart procedures has shown promise, but this specific assist system has limited prior randomized data.

Eligibility criteria

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.
11. Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
12. Stroke/TIA within 30 days or severe carotid stenosis (\>70% by ultrasound).
13. Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
14. Hemodynamic instability: Systolic blood pressure \<90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
15. Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
16. End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
17. Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
18. Pregnant or breastfeeding.
19. Participation in other clinical trials (drug/device) without meeting primary endpoints.
20. Other contraindications per investigator judgment.

Where this trial is running

Xiamen, Fujian

• Structural Heart Disease Unit, Xiamen Cardiovacular Hospital — Xiamen, Fujian, China (Recruiting)

Study contacts

• Study coordinator: Xiang Chen, Dr

Conditions Mitral R; Mitral Regurgitation