Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation: Development and Validation of a Predictive Model-A Multicenter Prospective Cohort Study

Mitral Regurgitation (MR) is the most prevalent type of valvular heart disease in clinical practice, with an average prevalence of approximately 1% in populations with moderate-to-severe or worse MR, which increases significantly with age. Functional MR (FMR) is one subtype of MR and can be further classified into atrial FMR, ventricular FMR, and mixed FMR based on its underlying mechanisms. Pathophysiologically, FMR is closely associated with atrial fibrillation (AF) and heart failure (HF). Studies suggest that catheter ablation for AF may improve FMR in some patients and reverse left atrial (LA) and left ventricular (LV) remodeling. However, there is currently a lack of precise and effective indicators or predictive models to determine the evolution of FMR after AF ablation in both domestic and international research. This study aims to conduct a multicenter prospective cohort study, enrolling patients with moderate or worse FMR and persistent AF undergoing ablation. Using postoperative 3-month FMR improvement as the primary outcome, we will employ big data mining and multimodal analysis to construct a predictive model for FMR progression after AF ablation and validate it through prospective multicenter testing. The findings will provide a scientific basis for clinical decision-making and precision medicine in this patient population.

NCT Number	NCT07096219
Lead Sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Collaborators: Shantou Central Hospital, Dongguan People's Hospital, Second Affiliated Hospital of Nanchang University, First Affiliated Hospital of Shantou University Medical College, West China Hospital, Zhongshan People's Hospital, Guangdong, China, Qingyuan People's Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Jiangmen Central Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, First Affiliated Hospital of Chongqing Medical University, Jiangxi Provincial People's Hopital, Guangdong Provincial People's Hospital, The University of Hong Kong-Shenzhen Hospital, First Affiliated Hospital of Xinjiang Medical University, Second Affiliated Hospital of Guangzhou Medical University, Second Xiangya Hospital of Central South University, Zhongnan Hospital, Ningbo Medical Center Lihuili Hospital, Sir Run Run Shaw Hospital, China-Japan Union Hospital, Jilin University, Xiangya Hospital of Central South University, Shanxi Cardiovascular Hospital, Second Affiliated Hospital of Xi'an Jiaotong University, Shenzhen People's Hospital, First Affiliated Hospital, Sun Yat-Sen University, Tongji Hospital, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Renmin Hospital of Wuhan University, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Air Force Medicial University, The First Affiliated Hospital of Nanchang University, The First Affiliated Hospital of Dalian Medical University, Jiangsu Provincial People's Hospital, Meizhou People's Hospital, Yuebei People's Hospital, The Third Xiangya Hospital of Central South University, Third Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital Xi'an Jiaotong University, Second Affiliated Hospital of Wenzhou Medical University, People's Hospital of Nanhai District
Conditions	AF Ablation Patients With Moderate+ FMR and Persistent AF
Enrollment	556 participants
Start Date	2024-12-31
Primary Completion	2026-12-30 (estimated)
Study Completion	2027-12-30 (estimated)
Updated on ClinicalTrials.gov	2026-06-18