Actively Recruiting
Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
Led by Beijing Anzhen Hospital · Updated on 2026-03-13
146
Participants Needed
17
Research Sites
159 weeks
Total Duration
On this page
Sponsors
B
Beijing Anzhen Hospital
Lead Sponsor
A
Abbott
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 within 14 days before randomization
- Age between 18 and 80 years
- Diagnosed with persistent atrial fibrillation by electrocardiogram
- Left ventricular ejection fraction of 50% or higher confirmed within 14 days before randomization
- Left ventricular end-diastolic diameter and left atrial anterior-posterior diameter of 60 mm or less confirmed within 14 days before randomization
- Agree to undergo catheter ablation and able to attend required follow-up visits
You will not qualify if you...
- Paroxysmal atrial fibrillation or atrial fibrillation due to reversible causes, or history of previous ablation
- Primary mitral valve diseases such as calcification, sclerosis, prolapse, flail, tendon rupture, degeneration, infection, rheumatic or ischemic lesions
- Previous mitral valve surgery or transcatheter procedures
- Mitral valve orifice area less than 4 cm²
- Aortic valve disease needing surgical or transcatheter intervention
- Untreated significant coronary artery disease requiring revascularization
- History of myocardial infarction
- Diagnosis of cardiomyopathies including dilated, hypertrophic, restrictive, constrictive, arrhythmogenic, or infiltrative types
- Evidence of intracardiac mass or thrombus on echocardiogram
- Implanted cardiac devices such as pacemaker or defibrillator
- Hemodynamic instability needing cardiac assist devices or support
- Recent percutaneous cardiac intervention within 30 days before randomization
- Cardiac surgery within 6 months before randomization
- Active infections requiring antibiotics
- Known allergy or contraindication to procedure medications
- Contraindication to appropriate anticoagulation therapy
- Chronic obstructive pulmonary disease requiring continuous oxygen or steroids
- Recent stroke within 30 days or severe stroke disability
- Severe carotid artery narrowing over 70%
- Planned surgery or intervention within next 3 months
- Liver or kidney failure or dialysis
- Pregnant or planning pregnancy within 3 months
- Life expectancy under 12 months due to conditions like advanced cancer
- Participation in other interventional studies
- Any condition making study participation unsuitable by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
C
Caihua Sang, MD
CONTACT
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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