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

Launched by XIAMEN CARDIOVASCULAR HOSPITAL, XIAMEN UNIVERSITY · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new system called the Structural Heart Surgery Assist System to help perform a heart procedure known as transcatheter mitral valve edge-to-edge repair (TEER). This procedure is used to treat mitral regurgitation, a condition where the heart’s mitral valve doesn’t close properly, causing blood to flow backward. The trial aims to see if using this new system is as safe and effective as the current manual method, such as the MitraClip device, for patients with moderate to severe mitral valve leakage.

People who might be eligible for this study are adults with significant mitral valve leakage who have symptoms and are considered high-risk for traditional surgery or have certain heart conditions. Participants will be randomly assigned to either receive the TEER procedure with the new assist system or the usual manual method. Before the procedure, patients will undergo heart imaging to confirm the severity of the valve leak. The study involves follow-up visits to monitor safety and how well the valve repair works. If you or a loved one has mitral valve leakage and surgery is risky or not an option, this trial could be a potential option to discuss with your doctor.

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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.