NCT07096219

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started Dec 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Dec 2024Dec 2027

Study Start

First participant enrolled

December 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

AF Ablation Patients With Moderate+ FMR and Persistent AF

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint was MR improvement at 3 months post-procedure.

    MR improvement was defined as a reduction in regurgitation severity by ≥1 grade on 3-month post-ablation transthoracic echocardiography (TTE) compared to baseline. Absence of improvement or worsening was categorized as non-improvement.

    From the operation day to 3 months after operation.

Study Arms (1)

Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation

Procedure: Catheter AblationDiagnostic Test: ultrasonic cardiography (UCG)

Interventions

Catheter AblationPROCEDURE

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

Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation
ultrasonic cardiography (UCG)DIAGNOSTIC_TEST

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

Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with moderate-to-severe functional mitral regurgitation (FMR) and persistent atrial fibrillation undergoing catheter ablation

You may qualify if:

  • Aged 18-75 years
  • Diagnosis of functional mitral regurgitation (FMR) by transthoracic echocardiography (TTE) and/or transesophageal echocardiography (TEE) with combined qualitative and quantitative assessment, demonstrating moderate or worse regurgitation (≥ grade 2+)
  • Persistent atrial fibrillation (AF) with successful catheter ablation
  • Signed informed consent with commitment to regular follow-up for ≥1 year

You may not qualify if:

  • Acute or chronic degenerative mitral regurgitation (DMR) from any etiology
  • Paroxysmal or permanent atrial fibrillation
  • Planned repeat ablation for AF recurrence
  • Concomitant moderate/severe valvular disease (e.g., mitral stenosis, aortic stenosis/regurgitation, pulmonary stenosis/regurgitation)
  • Prior valvular surgery/intervention
  • History of open-heart surgery
  • Severe pulmonary hypertension (PASP \>70 mmHg) refractory to medical therapy
  • Left atrial diameter ≥60 mm (diastolic phase) on echocardiography
  • Uncontrolled hyperthyroidism
  • Intracardiac mass/thrombus/vegetation
  • Significant shunts (ASD/VSD/PDA)
  • Hypertrophic obstructive cardiomyopathy
  • Active severe infection/sepsis (including infective endocarditis)
  • Scheduled CRT/CRT-D/CCM implantation
  • Untreated critical CAD (e.g., ≥70% stenosis in proximal/mid LAD/LCX/RCA requiring revascularization) or concomitant major cardiovascular surgery needs
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Interventions

Catheter Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Yangxin Chen, PhD

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

December 31, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)