Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
ELEVATE-AF
2 other identifiers
interventional
146
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 11, 2025
CompletedFirst Posted
Study publicly available on registry
March 19, 2025
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 13, 2026
March 1, 2026
2.3 years
March 11, 2025
March 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint is the proportion of patients with residual MR of moderate [2+] or less assessed by transthoracic echocardiography at 3 months.
The primary endpoint is the proportion of patients with residual MR of moderate \[2+\] or less assessed by transthoracic echocardiography at 3 months. MR severity is confirmed by the Echocardiography Core Lab according to the American Society of Cardiac Ultrasound criteria (mitral effective regurgitant orifice area \[EROA)\]≤20 mm2).
3 month
Secondary Outcomes (17)
all-cause mortality
3 month
cardiovascular hospitalization
3 month
undergoing interventional or surgical treatment of mitral valve
3 month
heart failure hospitalization or emergency room visit
3 month
Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) score change between baseline and 3 month
3 month
- +12 more secondary outcomes
Other Outcomes (5)
perioperative procedural complications
3 months
major bleeding (ISTH definition)
3 months
stroke and systemic embolism
3 months
- +2 more other outcomes
Study Arms (2)
Catheter ablation plus medication group
EXPERIMENTALAll patients assigned to the catheter ablation group will receive AF catheter ablation and receive the same medical therapy as the control group.
Medication group
ACTIVE COMPARATORAll patients should receive guideline-directed medical therapy, anticoagulation, and rate control with medications according to the guidelines.
Interventions
All patients will receive atrial fibrillation catheter ablation. They also should receive guideline-directed medical therapy, anticoagulation, and rate control with medications according to the guidelines.
Patients will receive guideline-directed medical therapy, anticoagulation, and rate control according to the guidelines for the management of AF and heart failure.
Subsequent ablations may be considered for patients with recurrence，and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.
All patients could receive catheter ablation if the procedure is needed, and the medical therapy for ELEVATE-AF X is identical to that of the ELEVATE-AF trial.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Anzhen Hospitallead
- Abbottcollaborator
Study Sites (17)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, 361006, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510000, China
The Second Hospital of Hebeimedical University
Shijiazhuang, Hebei, 050000, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 450052, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The first hospital of Jilin University
Changchun, Jilin, 130000, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750002, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, 250000, China
Tangdu Hospital-Air Force Medical University
Xi’an, Shanxi, 710000, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Changsheng Ma, MD
Beijing Anzhen Hospital
- PRINCIPAL INVESTIGATOR
Caihua Sang, MD
Beijing Anzhen Hospital
Central Study Contacts
Caihua Sang, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Cardiology Department, Beijing Anzhen Hospital, Capital Medical University, Director of Beijing Cardiovascular Disease Prevention Office and Director of Department of Cardiology in Capital Medical University
Study Record Dates
First Submitted
March 11, 2025
First Posted
March 19, 2025
Study Start
April 8, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
May 1, 2028
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share