NCT06883864 Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
| NCT ID | NCT06883864 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 146 participants in total. It began in 2025-04-08 with a primary completion date of 2027-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Changsheng Ma, MD
PRINCIPAL INVESTIGATOR
Beijing Anzhen Hospital
Frequently Asked Questions
Who can join the NCT06883864 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883864 currently recruiting?
Yes, NCT06883864 is actively recruiting participants. Contact the research team at theliu@139.com for enrollment information.
Where is the NCT06883864 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Xiamen, China and 11 additional locations.
Who is sponsoring the NCT06883864 clinical trial?
NCT06883864 is sponsored by Beijing Anzhen Hospital. The principal investigator is Changsheng Ma, MD at Beijing Anzhen Hospital. The trial plans to enroll 146 participants.
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