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

Enrolling by invitation

Conditions studied: AF Ablation Patients With Moderate+ FMR and Persistent AF

In brief

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.

Key facts

Study ID: NCT07096219
Run by: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
People needed: 556
Starts: 2024-12-31
Expected to finish: 2027-12-30
Last updated by the study team: 2026-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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

Full record on ClinicalTrials.gov

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