Comparing bi-atrial and left atrial ablation for atrial fibrillation in patients with rheumatic mitral valve disease
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial
This study is testing whether a more extensive heart procedure called bi-atrial ablation works better than the usual left atrial ablation for treating persistent atrial fibrillation in patients with rheumatic mitral valve disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | China National Center for Cardiovascular Diseases Government |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT05021601 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of bi-atrial ablation versus left atrial ablation in treating persistent atrial fibrillation during mitral valve surgery for patients with rheumatic mitral valve disease. Atrial fibrillation is common in these patients and can lead to serious complications such as stroke. The research will evaluate whether a more extensive bi-atrial ablation approach offers better outcomes compared to the traditional left atrial ablation. The study will involve patients who meet specific criteria, including age and diagnosis of persistent atrial fibrillation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with persistent or long-standing persistent atrial fibrillation and rheumatic mitral valve disease requiring surgery.
Not a fit: Patients with paroxysmal atrial fibrillation or those with degenerative or ischemic mitral valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with rheumatic mitral valve disease and persistent atrial fibrillation.
How similar studies have performed: While there is limited evidence comparing bi-atrial and left atrial ablation in this specific patient population, similar approaches have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year). * Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis). * Consent to surgical ablation of AF Exclusion Criteria: * Paroxysmal AF * Degenerative or ischemic mitral valve disease * Evidence of active infection * Previous catheter ablation or surgical ablation for AF * Surgical management of hypertrophic obstructive cardiomyopathy * Absolute contraindications for anticoagulation therapy * Left atrial thrombosis (not including left atrial appendage thrombosis alone) * Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)\<30% anticipated value) * Uncontrolled hypo- or hyperthyroidism * Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study * Left atrial diameter\>70mm * Right ventricular dysfunction (TAPSE\<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) \>60mmHg * Coronary artery bypass grafting is required for participants with coronary heart disease * Previous cardiac surgery * Refuse to participate in this study
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Fuwai Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Zhe Zheng, MD,PhD
- Email: zhengzhe@fuwai.com
- Phone: : +86-010-88396051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.