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

NCT07096219 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 556

Last updated 2025-07-31

No results posted yet for this study

Summary

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.

Conditions

  • AF Ablation Patients With Moderate+ FMR and Persistent AF

Interventions

PROCEDURE

Catheter Ablation

A minimally invasive procedure that delivers energy through catheters to destroy abnormal cardiac tissue causing arrhythmias.

DIAGNOSTIC_TEST

ultrasonic cardiography (UCG)

Trans-thoracic echocardiography (TTE) is performed in the resting position. Trans-esophageal echocardiography (TEE) is performed under surfa

Sponsors & Collaborators

  • Shantou Central Hospital

    collaborator OTHER
  • Dongguan People's Hospital

    collaborator OTHER_GOV
  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER
  • First Affiliated Hospital of Shantou University Medical College

    collaborator OTHER
  • West China Hospital

    collaborator OTHER
  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER
  • Qingyuan People's Hospital

    collaborator OTHER
  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    collaborator OTHER
  • Jiangmen Central Hospital

    collaborator OTHER
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

    collaborator OTHER
  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER
  • Jiangxi Provincial People's Hopital

    collaborator OTHER
  • Guangdong Provincial People's Hospital

    collaborator OTHER
  • Nanhai District People's Hospital of Foshan City

    collaborator UNKNOWN
  • The University of Hong Kong-Shenzhen Hospital

    collaborator OTHER
  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER
  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Second Xiangya Hospital of Central South University

    collaborator OTHER
  • Zhongnan Hospital

    collaborator OTHER
  • Ningbo Medical Center Li Huili Hospital

    collaborator UNKNOWN
  • Sir Run Run Shaw Hospital

    collaborator OTHER
  • China-Japan Union Hospital, Jilin University

    collaborator OTHER
  • Xiangya Hospital of Central South University

    collaborator OTHER
  • Shanxi Cardiovascular Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Xi'an Jiaotong University

    collaborator OTHER
  • Shenzhen People's Hospital

    collaborator OTHER
  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • Tongji Hospital

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • First People's Hospital of Foshan

    collaborator OTHER
  • Renmin Hospital of Wuhan University

    collaborator OTHER
  • Guizhou Provincial People's Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Air Force Medical University

    collaborator UNKNOWN
  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER
  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER
  • Jiangsu Provincial People's Hospital

    collaborator OTHER
  • Meizhou People's Hospital

    collaborator OTHER
  • Yuebei People's Hospital

    collaborator OTHER
  • The Third Xiangya Hospital of Central South University

    collaborator OTHER
  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER
  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER
  • Second Affiliated Hospital of Wenzhou Medical University

    collaborator OTHER
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Yangxin Chen, PhD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-31
Primary Completion
2026-12-30
Completion
2027-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07096219 on ClinicalTrials.gov