Actively Recruiting
Efficacy and Safety of Catheter Ablation in Patients With Severe Mitral Regurgitation and Persistent Atrial Fibrillation: a Randomized Controlled Trial (ELEVATE-AF)
Led by Beijing Anzhen Hospital · Updated on 2026-03-13
146
Participants Needed
17
Research Sites
39 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial investigates treatments for patients with persistent atrial fibrillation (AF) combined with severe atrial functional mitral regurgitation (MR), a condition where AF worsens mitral valve leakage and heart function. The study aims to compare catheter ablation plus medication versus medication alone to see which better reduces MR severity and improves patient outcomes. It is designed as a randomized controlled trial enrolling 146 patients at multiple sites in China. Participants will be randomly assigned to either receive catheter ablation combined with guideline-directed medical therapy, anticoagulation, and rate control medications or to receive medical therapy alone. The trial includes an initial 3-month follow-up assessing MR severity via echocardiography, with secondary outcomes including mortality, hospitalizations, quality of life, and heart rhythm measures. After this, an extension study (ELEVATE-AF X) will continue for up to 12 months to evaluate long-term outcomes and allow further ablation if needed. During the study, participants will undergo transthoracic echocardiography, clinical assessments, questionnaires on quality of life, and monitoring for any arrhythmia episodes. Researchers will track safety outcomes such as surgical complications, bleeding, stroke, and systemic embolism. The study carefully measures changes in MR severity, heart function, and patient well-being over time, with active follow-up visits through the first year.
CONDITIONS
Brief Title
Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate-to-severe or greater atrial functional mitral regurgitation confirmed by echocardiography
- Age between 18 and 80 years
- Diagnosed with persistent atrial fibrillation by electrocardiogram
- Left ventricular ejection fraction of 50% or higher
- Left ventricular end-diastolic diameter of 60 mm or less and left atrial anterior-posterior diameter of 60 mm or less
- Willing to undergo catheter ablation and able to comply with follow-up requirements
You will not qualify if you...
- Paroxysmal atrial fibrillation or atrial fibrillation caused by reversible conditions
- History of previous ablation or mitral valve surgery
- Primary mitral valve problems such as calcification, prolapse, sclerosis, or infection
- Mitral valve orifice area less than 4 cm2
- Aortic valve disease needing surgery or intervention
- Untreated serious coronary artery disease needing revascularization
- History of heart attack
- Diagnosed cardiomyopathies like dilated or hypertrophic cardiomyopathy
- Heart masses or clots seen on echocardiography
- Implanted cardiac devices like pacemakers or defibrillators
- Hemodynamic instability requiring mechanical support
- Recent cardiac interventions or surgery within specified timeframes
- Active infections needing antibiotics
- Allergy or contraindications to study medications or anticoagulation
- Severe lung disease requiring oxygen or steroids
- Recent stroke or severe carotid artery narrowing
- Other planned surgeries within 3 months
- Liver or kidney failure or dialysis
- Pregnancy or planning pregnancy soon
- Life expectancy less than 12 months
- Participation in other interventional studies
- Any condition making study participation unsuitable as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants are assigned to either catheter ablation combined with medication or medication alone to manage persistent atrial fibrillation and severe mitral regurgitation.
Visits occur as needed for catheter ablation procedure and medication management during the treatment period
Duration - Up to 12 months
Participants are monitored for outcomes including mitral regurgitation severity, arrhythmia recurrence, quality of life, and hospitalizations after the treatment period.
Regular follow-up visits through 12 months post-treatment to assess long-term outcomes
Trial Site Locations
Total: 17 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
2
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
3
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
4
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, China, 361006
Not Yet Recruiting
5
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
6
The Second Hospital of Hebeimedical University
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
7
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Actively Recruiting
8
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 450052
Actively Recruiting
9
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
10
Wuhan Asia Heart Hospital
Wuhan, Hubei, China, 430022
Actively Recruiting
11
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
12
The first hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
13
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China, 750002
Actively Recruiting
14
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China, 250000
Actively Recruiting
15
Tangdu Hospital-Air Force Medical University
Xi’an, Shanxi, China, 710000
Actively Recruiting
16
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
17
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
L
liu HE, MD
C
Caihua Sang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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