Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsist… (NCT06883864) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
China146 participantsStarted 2025-04-08
Plain-language summary
Atrial fibrillation (AF) leads to atrial functional mitral regurgitation (MR) through mechanisms including mitral annular dilatation, systolic leaflet motion distance alteration, and contractility decrease. Compared with primary MR, atrial functional MR due to AF and other diseases tends to have a worse prognosis, with a higher risk of death and heart failure hospitalization. MR and AF co-exist and exacerbate left atrial dysfunction, further causing worse cardiac dysfunction, valvular regurgitation, and aggravating prognosis.
The best therapy for secondary MR is unclear because MR is only one component of the disease, and restoration of mitral valve competence is not curative. Catheter ablation improves symptoms and cardiac function in patients with AF, reduces risks of AF recurrence and hospitalization, as well as increases quality of life. For patients with AF combined with functional moderate-to-severe MR, previous observational studies have found that the severity of MR significantly reduced after taking catheter ablation to restore sinus rhythm. We hypothesized that catheter ablation would significantly improve the severity of MR in patients with severe atrial functional MR combined with persistent AF compared with drug therapy alone.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients were required to have moderate-to-severe or greater (≥3+) atrial functional mitral regurgitation assessed by transthoracic echocardiography within 14 days before randomization. Mitral regurgitation severity was graded by an echocardiography core-lab based on the American Society of Echocardiography criteria, specifically an effective regurgitant orifice area (EROA) ≥30 mm²
✓. Age 18-80 years
✓. Persistent atrial fibrillation diagnosed by electrocardiogram
✓. Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab)
✓. Left ventricular end-diastolic internal diameter ≤60 mm and left atrial anterior- posterior diameter ≤60 mm in echocardiographic parasternal long-axis view within 14 days before randomization(confirmed by the echocardiography core-lab)
✓. Agree to undergo catheter ablation and be able to undergo follow-up as required.
Exclusion criteria
✕. paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
What they're measuring
1
The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months.