Enrolling by Invitation

NCT Number: NCT07096219

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.

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Key information

Conditions

AF Ablation Patients With Moderate+ FMR and Persistent AF

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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
End-stage heart failure (ACC/AHA Stage D) requiring mechanical support/transplant listing
Severe hepatic dysfunction (acute liver failure/decompensated cirrhosis, Child-Pugh C)
Severe renal impairment (CKD 5: eGFR<15 mL/min or dialysis)
Hemodynamic instability (SBP<90 mmHg/MAP<70 mmHg with hypoperfusion [urine output<30 mL/h])
Contraindications to antithrombotics: Active bleeding (GI/intracranial/visceral), bleeding disorders (hemophilia/ITP/leukemia etc.), severe hematologic abnormalities (platelets<20×10⁹/L, spontaneous INR>3)
Uncontrolled autoimmune/connective tissue disease
Acute MI within 4 weeks
Stroke within 30 days
Acute peptic ulcer/upper GI bleeding within 3 months
Pregnancy/lactation
Declined informed consent
Life expectancy <1 year
Poor compliance (anticipated inability to complete follow-up)
Concurrent participation in conflicting clinical trials
Other investigator-determined exclusions.

Treatment and study plan

Catheter ablation

Procedure

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

ultrasonic cardiography (UCG)

Diagnostic Test

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

Primary outcomes

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

Time frame: From the operation day to 3 months after operation.

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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

China-Japan Union Hospital, Jilin University
Dongguan People's Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Shantou University Medical College
First Affiliated Hospital of Xinjiang Medical University
First Affiliated Hospital, Sun Yat-Sen University
First People's Hospital of Foshan
Guangdong Provincial People's Hospital
Guizhou Provincial People's Hospital
Jiangmen Central Hospital
Jiangsu Provincial People's Hospital
Jiangxi Provincial People's Hopital
Meizhou People's Hospital
Nanfang Hospital, Southern Medical University
Ningbo Medical Center Lihuili Hospital
People's Hospital of Nanhai District
Qingyuan People's Hospital
Renmin Hospital of Wuhan University
Second Affiliated Hospital of Guangzhou Medical University
Second Affiliated Hospital of Nanchang University
Second Affiliated Hospital of Wenzhou Medical University
Second Affiliated Hospital of Xi'an Jiaotong University
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Xiangya Hospital of Central South University
Shantou Central Hospital
Shanxi Cardiovascular Hospital
Shenzhen People's Hospital
Sir Run Run Shaw Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The First Affiliated Hospital of Air Force Medicial University
The First Affiliated Hospital of Dalian Medical University
The First Affiliated Hospital of Nanchang University
The Third Xiangya Hospital of Central South University
The University of Hong Kong-Shenzhen Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Tongji Hospital
West China Hospital
Xiangya Hospital of Central South University
Yuebei People's Hospital
Zhongnan Hospital
Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

The Improvement Effect of Catheter Ablation on Functional Mitral Regurgitation in Patients With Persistent Atrial Fibrillation and the Construction and Validation of a Predictive Model: A Multicenter Prospective Cohort Study

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jul 31, 2025
Registry last updated: Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.