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RECRUITING
NCT06883864
NA

Efficacy and Safety of Catheter abLation in patiEnts With seVere mitrAl regurgiTation and pErsistent Atrial Fibrillation: a Randomized Controlled Trial

Sponsor: Beijing Anzhen Hospital

View on ClinicalTrials.gov

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

PROCEDURE

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.

DRUG

Medication

Patients will receive guideline-directed medical therapy, anticoagulation, and rate control according to the guidelines for the management of AF and heart failure.

PROCEDURE

(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.

PROCEDURE

(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