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

Official 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

Overview

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.

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

Primary outcome measures

• The primary endpoint was MR improvement at 3 months post-procedure. [Time frame: From the operation day to 3 months after operation.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 2 centers

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou
• Shantou Central Hospital — Shantou

Identifiers

NCT: NCT07096219 · SYSKY-2024-803-02 · SYSKY-2024-803-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗