Heart Procedure Study for Leaky Mitral Valve and Irregular Heartbeat
Studies a catheter procedure for an irregular heartbeat in adults with a leaky heart valve.
Plain-language title generated from the registry record
Registry title: Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation: Development and Validation of a Predictive Model-A Multicenter Prospective Cohort Study
Key facts
- Where
- Guangzhou and Shantou, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07096219, who can take part
Where in China
- Sun Yat Sen Memorial Hospital of Sun Yat sen UniversityGuangzhou, ChinaNo longer taking part
- Shantou Central HospitalShantou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Trial code
- NCT07096219
- Record updated
- 18 June 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Concomitant moderate/severe valvular disease (e.g., mitral stenosis, aortic stenosis/regurgitation, pulmonary stenosis/regurgitation); Prior valvular surgery/intervention; Untreated critical CAD (e.g., ≥70% stenosis in proximal/mid LAD/LCX/RCA requiring revascularization) or concomitant major cardiovascular surgery needs; Concurrent participation in conflicting clinical trials; History of open-heart surgery; Severe pulmonary hypertension (PASP >70 mmHg) refractory to medical therapy; Active severe infection/sepsis (including infective endocarditis); End-stage heart failure (ACC/AHA Stage D) requiring mechanical support/transplant listing; Severe hepatic dysfunction (acute liver failure/decompensated cirrhosis, Child-Pugh C); Uncontrolled autoimmune/connective tissue disease; Stroke within 30 days; Acute peptic ulcer/upper GI bleeding within 3 months; Severe renal impairment (CKD 5: eGFR<15 mL/min or dialysis); Contraindications to antithrombotics: Active bleeding (GI/intracranial/visceral), bleeding disorders (hemophilia/ITP/leukemia etc.), severe hematologic abnormalities (platelets<20×10⁹/L, spontaneous INR>3); Acute or chronic degenerative mitral regurgitation (DMR) from any etiology; Paroxysmal or permanent atrial fibrillation; Planned repeat ablation for AF recurrence; Left atrial diameter ≥60 mm (diastolic phase) on echocardiography; Uncontrolled hyperthyroidism; Intracardiac mass/thrombus/vegetation; Significant shunts (ASD/VSD/PDA); Hypertrophic obstructive cardiomyopathy; Scheduled CRT/CRT-D/CCM implantation; Hemodynamic instability (SBP<90 mmHg/MAP<70 mmHg with hypoperfusion [urine output<30 mL/h]); Acute MI within 4 weeks; Pregnancy/lactation; Declined informed consent; Life expectancy <1 year; Poor compliance (anticipated inability to complete follow-up); Other investigator-determined exclusions.