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NCT07744035

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

Sponsor: Mao Chen

View on ClinicalTrials.gov

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.

Official title: Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

384

Start Date

2026-09-01

Completion Date

2029-09-01

Last Updated

2026-08-04

Healthy Volunteers

Conditions

Atrial Functional Mitral Regurgitation Atrial Fibrillation (AF)

Interventions

DEVICE

Transcatheter edge to edge repair

Participants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization. TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.

PROCEDURE

Catheter ablation

Participants will undergo catheter ablation for persistent atrial fibrillation during the study period. The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.

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 MV surgery or transcatheter procedure * Need for any cardiac surgery (other than for MV disease) * Untreated clinically significant coronary artery disease * Echocardiographic evidence of intracardiac thrombus * Active infections requiring current antibiotic therapy * Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media * Pregnancy * Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits * Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment