Comparing two methods for repairing mitral regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: panxiangbin@fuwaihospital.org
• Phone: 8688396666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.