Not Yet RecruitingNot Applicable

Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation

384 participantsStarted 2026-09-01

Plain-language summary

This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Left ventricular ejection fraction ≥ 50% * Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml) * Valve morphology: MR originating from the mid portion of the valve; mitral valve area\> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth\< 11 mm, coaptation length\> 2 mm * Rate control in suspected AF-induced cardiomyopathy (heart rate \<80 bpm at rest and \<110 bpm during exercise) * Patients must be willing to comply with all follow-up requirements Exclusion Criteria: * Life expectancy\< 1 year due to non-cardiac conditions * Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or \<severe but extending into the leaflets), and/or any mixed pathology * Active endocarditis of the mitral valve or rheumatic mitral valve disease * Hypotension (systolic pressure \< 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure\> 70 mmHg * Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization * Any prior M…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial combines catheter ablation for atrial fibrillation with a MitraClip-type repair procedure for mitral regurgitation — is my heart condition caused by atrial fibrillation in the way this trial targets, and would my doctor consider me a potential candidate to even discuss with the research team?
2The trial is listed as 'not yet recruiting' — how long does my doctor think it might be before enrollment opens, and is waiting a realistic option given where my condition is right now?
3The trial uses something called a 'Win Ratio' as its main measurement, which ranks patients on a combination of outcomes rather than a single result — can my doctor explain what kinds of outcomes that likely includes, such as hospitalization or heart function, and what that means for understanding the study's results?
4Since this trial is listed as Phase NA, which often applies to device or procedural studies, what does my doctor think is currently known about the safety and effectiveness of combining these two procedures, compared to doing ablation or the valve repair separately?
5Are there standard treatment options my doctor would recommend I try first before considering a trial like this, or does my current situation make this kind of combined approach worth exploring sooner?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hierarchical Composite Clinical Endpoint (Win Ratio)

Timeframe: 12 months

Trial details

NCT IDNCT07744035

SponsorMao Chen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Zhengang Zhao

86-18980733914 zhaozhengang@foxmail.com

View on ClinicalTrials.gov More Atrial Functional Mitral Regurgitation trials