Catheter ablation for people with persistent atrial fibrillation and severe atrial functional mitral regurgitation

Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial(ELEVATE-AF)

This will test whether adding catheter ablation to usual medicines helps adults with persistent atrial fibrillation and moderate-to-severe or severe atrial functional mitral regurgitation reduce valve leakage and improve symptoms and outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Anzhen Hospital (Academic / other)
• Locations: 17 sites (Hefei, Anhui and 16 other locations)
• Trial ID: NCT06883864 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 with persistent atrial fibrillation, moderate-to-severe or severe atrial functional mitral regurgitation, preserved left ventricular ejection fraction, and acceptable cardiac chamber sizes who can undergo ablation and follow-up are ideal candidates.

Not a fit: Patients with primary (degenerative) mitral valve disease, reduced LVEF below the trial threshold, marked left ventricular dilation, or who cannot undergo catheter ablation or required follow-up are less likely to benefit from this approach.

Why it matters

Potential benefit: If successful, adding catheter ablation could reduce the severity of mitral regurgitation, improve symptoms and quality of life, and lower hospitalization and intervention rates for these patients.

How similar studies have performed: Observational studies have suggested catheter ablation can improve mitral regurgitation and symptoms in this population, but randomized evidence is limited, so this randomized trial addresses a relatively novel question.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 16 other locations

• 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)
• Xiamen University Affiliated Cardiovascular Hospital — Xiamen, Fujian, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_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)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Wuhan Asia Heart Hospital — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China (Recruiting)
• Shandong Provincial Qianfoshan Hospital — Jinan, Shandong, China (Recruiting)
• Tangdu Hospital-Air Force Medical University — Xi’an, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Not_yet_recruiting)
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Changsheng Ma, MD — Beijing Anzhen Hospital
• Study coordinator: liu HE, MD

Conditions Atrial Fibrillation; Catheter Ablation; Atrial Functional Mitral Regurgitation; atrial fibrillation; mitral regurgitation; catheter ablation