Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Detailed Description
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Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

Official Title
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Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation With Right Atrial Enlargement

Conditions
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Atrial Fibrillation, Persistent

Intervention / Treatment
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* Procedure: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines; Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment. Exclusion Criteria: Uncontrolled congestive heart failure; History of severe valve disease and/or prosthetic valve replacement; Myocardial infarction or stroke within 6 months; Severe congenital heart disease; EF <40%; Contrast agent allergy; The use of anticoagulant drugs is contraindicated; Severe lung disease; Left atrial thrombus confirmed by preoperative esophageal ultrasound; Contraindications for cardiac catheterization; Atrial fibrillation ablation; Have performed any cardiac surgery within 2 months; Poor general health; Life expectancy < 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RA group<br>The RA group received adjunctive right atrial ablation in addition to left side ablation. | Procedure: Catheter ablation<br>* The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation<br>|
| Active Comparator: Control group<br>The control group received left side ablation only. | Procedure: Catheter ablation<br>* The ablation approach includes: pulmonary vein isolation, left side linear ablation, left side driver ablation and right atrial driver ablation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrence | any AF episodes lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs at 12 months after a single procedure. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation/atrial tachycardia recurrence | any documented AF/AT episode lasting more than 30 seconds after the blanking period without anti-arrhythmic drugs treatment at 12 months after a single procedure or freedom from any AF episodes lasting more than 30 seconds occurring after the blanking period without the use of anti-arrhythmic drugs at the end of study follow-up after a single procedure. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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catheter ablation, atrial fibrillation, Driver ablation