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Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial
Sponsor: Beijing Anzhen Hospital
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.
Official title: Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial(ELEVATE-AF)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
146
Start Date
2025-04-08
Completion Date
2028-05-01
Last Updated
2026-03-13
Healthy Volunteers
No
Interventions
Catheter ablation plus medication
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.
Medication
Patients will receive guideline-directed medical therapy, anticoagulation, and rate control according to the guidelines for the management of AF and heart failure.
(ELEVATE-AF X) experimental group
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.
(ELEVATE-AF X) control group
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.
Locations (17)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xiamen University Affiliated Cardiovascular Hospital
Xiamen, Fujian, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The Second Hospital of Hebeimedical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
The first hospital of Jilin University
Changchun, Jilin, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
Tangdu Hospital-Air Force Medical University
Xi’an, Shanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China