Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.

Detailed Description
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Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD. Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.

Official Title
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Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation: a Multicenter, Prospective, Randomized Controlled Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Bi-atrial ablation
* Procedure: Left atrial ablation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bi-atrial ablation group<br>Participants in this group will receive mitral valve surgery concomitant with bi-atrial ablation procedure. | Procedure: Bi-atrial ablation<br>* This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.<br>|
| Active Comparator: Left atrial ablation group<br>Participants in this group will receive mitral valve surgery concomitant with left atrial ablation procedure. | Procedure: Left atrial ablation<br>* This intervention includes mitral valve surgery concomitant with left atrial ablation alone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate without any recurrence of atrial tachyarrhythmias in the absence of antiarrhythmic drugs | Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring in the absence of antiarrhythmic drugs. | At 12-month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate without permanent pacemaker implantation (Key secondary outcome) | Percentage of participants who did not have a new permanent pacemaker implanted. | At 12-month after intervention | 
| Survival rate without any recurrence of atrial tachyarrhythmias with antiarrhythmic drugs | Without detections of atrial fibrillation, atrial flutter, or other atrial tachyarrhythmias with a duration of greater than 30 seconds documented by 3-day Holter monitoring with antiarrhythmic drugs. | At 12-month after intervention | 
| Burden of atrial fibrillation | Burden of atrial fibrillation according to 3-day Holter monitoring. | At 12-month after intervention | 
| Major adverse events | Including cardiac death, stroke, heart failure requiring rehospitalization, embolic events or bleeding events requiring rehospitalization. | At 12-month after intervention | 
| Cardiac function | Documented by echocardiography (left ventricular ejection fraction). | At 12-month after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatic mitral valve disease, Surgical ablation, Mitral valve surgery