Status:
NOT_YET_RECRUITING
Efficacy and Safety of Catheter abLation in patiEnts With seVere Atrial Functional Mitral regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
Lead Sponsor:
Beijing Anzhen Hospital
Collaborating Sponsors:
Abbott
Conditions:
Atrial Fibrillation (AF)
Catheter Ablation
Eligibility:
All Genders
18-80 years
Phase:
NA
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 dec...
Detailed Description
The ELEVATE-AF is a multi-center, open-label, parallel design, randomized controlled trial. Eligible subjects will be randomized in a 1:1 ratio to the catheter ablation combined with drug group or to ...
Eligibility Criteria
Inclusion
- 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)
- Within 14 days before randomization, patients must be treated to ensure the absence of fluid retention and to maintain an average heart rate below 110 bpm.
- Agree to undergo catheter ablation and be able to undergo follow-up as required.
- For the ELEVATE-AF X study: Subjects have to meet the ELEVATE-AF study eligibility criteria to be registered in the ELEVATE-AF X study.
Exclusion
- paroxysmal atrial fibrillation, atrial fibrillation secondary to an apparently reversible cause, or with history of previous ablation;
- primary mitral valve pathology, including calcification, sclerosis, prolapse, flail, tendon cable rupture, valve degeneration, infective endocarditis, rheumatic lesions, or ischemic lesions;
- history of previous mitral valve surgery or transcatheter manipulation;
- mitral valve orifice area \<4 cm2;
- aortic valve disease requiring surgical or transcatheter intervention;
- untreated clinically significant coronary artery disease requiring revascularization;
- history of previous myocardial infarction;
- 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)
- echocardiographic evidence of intracardiac mass or thrombus;
- implant of cardiac device (pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device, or left atria appendage closure);
- hemodynamic instability requiring cardiac assist devices, intra-aortic balloon pump (IABP), or other hemodynamic support;
- any percutaneous cardiac intervention (percutaneous coronary intervention, transcatheter aortic valve replacement, etc.) within the 30 days prior to randomization,
- any cardiac surgery within the 6 months prior to randomization;
- active infections requiring current antibiotic therapy;
- a known hypersensitivity or contradiction to procedure medications which cannot be adequately managed medically;
- contraindication to appropriate anti-coagulation therapy;
- chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic oral steroid therapy;
- acute cerebrovascular accident within 30 days prior to randomization or Modified Rankin Score ≥ 4;
- symptomatic severe carotid stenosis (\>70% by ultrasound);
- other planned surgical or interventional procedures within the next 3 months;
- liver failure;
- renal failure or dialysis status;
- pregnant or planning pregnancy within the next 3 months;
- life expectancy \< 12 months (e.g., advanced malignant tumors);
- currently participating in other interventional studies;
- circumstances that, in the judgment of the researcher, make participation in this study unsuitable.
- For the ELEVATE-AF X study: Subjects who have any contraindications to ELEVATE-AF study and are not capable of performing ELEVATE-AF study per investigator's assessment should not be registered in the ELEVATE-AF X study.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT06883864
Start Date
April 1 2025
End Date
December 1 2026
Last Update
March 20 2025
Active Locations (2)
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1
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
2
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009