Catheter ablation for people with persistent atrial fibrillation and severe atrial functional 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 is a multicenter, open-label, randomized 1:1 trial that will enroll 146 adults with persistent atrial fibrillation and moderate-to-severe or severe atrial functional mitral regurgitation and randomize them to catheter ablation plus medication versus medication alone. The primary outcome is the proportion of patients with residual mitral regurgitation of moderate (2+) or less on transthoracic echocardiography at 3 months, with MR severity confirmed by a central echocardiography core lab. Secondary outcomes include mortality, cardiovascular and heart-failure hospitalizations, need for mitral valve intervention, quality-of-life scores, freedom from atrial arrhythmias, and atrial fibrillation burden, and safety endpoints include peri-procedural complications and major bleeding. The trial is conducted at multiple tertiary hospitals in China with follow-up visits and echocardiographic assessments specified in the protocol.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Age 18-80 years
3. Persistent atrial fibrillation diagnosed by electrocardiogram
4. Left ventricular ejection fraction ≥50% assessed by transthoracic echocardiography within 14 days before randomization(confirmed by the echocardiography core-lab)
5. 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)
6. Agree to undergo catheter ablation and be able to undergo follow-up as required.

Exclusion Criteria:

1. paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
2. primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions;
3. history of previous mitral valve surgery or transcatheter manipulation;
4. mitral valve orifice area \<4 cm2;
5. aortic valve disease requiring surgical or transcatheter intervention;
6. untreated clinically significant coronary artery disease requiring revascularization;
7. history of previous myocardial infarction;
8. previous definitive diagnosis of cardiomyopathies such as dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, arrhythmogenic cardiomyopathy, and infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, and nodular disease)
9. echocardiographic evidence of intracardiac mass or thrombus;
10. implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure);
11. hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support;
12. any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization,
13. any cardiac surgery within the 6 months prior to randomization;
14. active infections requiring current antibiotic therapy;
15. a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically;
16. contraindication to appropriate anti-coagulation therapy;
17. chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy;
18. acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4;
19. symptomatic severe carotid stenosis (\>70% by ultrasound);
20. other planned surgical or interventional procedures within the next 3 months;
21. liver failure;
22. renal failure or dialysis status;
23. pregnant or planning pregnancy within the next 3 months;
24. life expectancy \< 12 months (e.g., advanced malignant tumors);
25. currently participating in other interventional studies;
26. circumstances that, in the judgment of the researcher, make participation in this study unsuitable.

Where it's running

• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Beijing Anzhen Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Second Hospital of Hebeimedical University
  Shijiazhuang, Hebei, China Recruiting
• The First Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• The Second Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Principal investigator: Changsheng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: liu HE, MD
• Email: theliu@139.com
• Phone: +86 13810720787

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

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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.