Comparing two methods for repairing mitral regurgitation

A Randomized Clinical Trial of Transcatheter Edge-to-edge Repair for Mitral Regurgitation Under Fully Echocardiographic Guidance Compared with Under Combined Guidance of Both Echocardiography and Fluoroscopy (ECHO-CLIP Study)

This study is testing whether using only ultrasound guidance for a heart repair procedure is as effective and safe as using both ultrasound and X-ray for older adults with mitral regurgitation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (other)
• Drugs / interventions: radiation
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT06684171 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of transcatheter edge-to-edge repair (TEER) for mitral regurgitation using echocardiographic guidance alone versus a combination of echocardiography and fluoroscopy. Mitral regurgitation is a common heart condition, particularly in older adults, and the study aims to reduce radiation exposure associated with the conventional method. Participants will be randomly assigned to one of the two procedural approaches to assess outcomes and efficacy. The study is designed to confirm the safety and effectiveness of a fully echo-guided TEER procedure.

Who should consider this trial

Good fit: Ideal candidates include symptomatic patients with significant mitral regurgitation who are at high surgical risk.

Not a fit: Patients with recent myocardial infarction or those requiring other concurrent cardiac procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a safer and less invasive treatment option for patients with mitral regurgitation.

How similar studies have performed: Previous studies have shown success with TEER procedures, but this specific approach using only echocardiographic guidance is novel.

Eligibility criteria

Inclusion Criteria:

\*Subjects meet either the first or second inclusion criteria in combination with the third and fourth ones were eligible.

1. Symptomatic DMR subjects with MR ≥ 3+ at high surgical risk in terms of STS Predicted Risk of Mortality replacement score ≥ 8 or STS Predicted Risk of Mortality repair score ≥ 6.\*
2. FMR subjects with LVESD ≤ 70 mm and MR ≥ 3+, despite administration of GDMT for 30 days.\*
3. MV anatomy appropriate for TEER procedure.
4. Subjects willing to participate in this study and complete the follow-up on schedule after obtaining informed consent.

Exclusion Criteria:

1. Myocardial infarction within 12 weeks prior to randomization.
2. Need for concurrent other cardiac procedures.
3. Any endovascular intervention or surgery within 30 days prior to randomization.
4. LVEF \< 20%.
5. MV orifice area \< 4.0 cm2.
6. Pulmonary artery systolic pressure \> 70 mmHg, as determined by echocardiogram.
7. Severe mitral annular calcification.
8. Unsuitable MV anatomy potentially precluding clip implantation: leaflet calcification or significant leaflet cleft in the grasping zone.
9. Previous MV surgery or current implanted ventricular assist device or current implanted mechanical prosthetic valve.
10. Any intracardiac mass, thrombus, or vegetation, as evidenced by echocardiogram.
11. Active endocarditis or rheumatic heart disease.
12. History of DVT or PE.

Abbreviations: DMR, degenerative mitral regurgitation; MR, mitral regurgitation; STS, Society of Thoracic Surgeons; FMR, functional mitral regurgitation; LVESD, left ventricular end-systolic diameter; GDMT, guideline-directed medical therapy; TEER, transcatheter edge-to-edge repair; LVEF, left ventricular ejection fraction; MV, mitral valve; DVT, deep venous thrombosis; PE, pulmonary embolism.

Where this trial is running

Shenzhen, Guangdong

• Fuwai Hospital Chinese Academy of Medical Sciences Shenzhen — Shenzhen, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Xiangbin Pan — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Xiangbin Pan

Conditions: Mitral Regurgitation, mitral regurgitation, transcatheter edge-to-edge repair, ECHO-CLIP, randomized clinical trail, ultrasound, echo