NCT07096219Enrolling by invitation
Catheter Ablation for Functional Mitral Regurgitation in Persistent Atrial Fibrillation: Development and Validation of a Predictive Model-A Multicenter Prospective Cohort Study
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
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 556 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 31 Dec 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07096219
What you commit to
- Study type: Observational
- Planned participants: 556
- From 31 Dec 2024 to the primary completion date, 30 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- 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)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat Sen Memorial Hospital of Sun Yat sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Shantou Central Hospital Coordinator of this site? Confirm its status | Shantou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.