Persistent Atrial Fibrillation Ablation Trial

Study Overview
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Brief Summary
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Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.

Official Title
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Persistent Atrial Fibrillation Ablation Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Surgical AF ablation
* Procedure: Percutaneous AF ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic persistent or long-standing AF suitable for AF ablation. Age over 18 years old. Informed consent to participate in this study. Exclusion Criteria: Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe. Unable to undergo general anaesthesia for AF ablation. Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery. Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery. Previous thoracic surgery. Participation in a conflicting study. Potential participants who are mentally incapacitated and cannot consent or comply with follow-up Pregnancy Other cardiac rhythm disorders

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pecutaneous AF ablation<br>Percutaneous catheter ablation of atrial fibrillation | Procedure: Percutaneous AF ablation<br>* Percutaneous catheter ablation of atrial fibrillation<br>|
| Active Comparator: Surgical AF ablation<br>Minimally invasive thoracoscopic surgical ablation of atrial fibrillation | Procedure: Surgical AF ablation<br>* Minimally invasive thoracoscopic surgical ablation of atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of persistent AF by 12 months after ablation | Mean time to recurrence of persistent AF after ablation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AF burden after AF ablation | Detected by ILR | 12 months | 
| Time to first episode of symptomatic AF after ablation | Time to first episode of symptomatic AF after ablation | 12 months | 
| Time to first episode of any AF after ablation | As detected by ILR | 12 months | 
| Total number of AF episodes after AF ablation | As detected by ILR, outside blanking period | 12 months | 
| Total number of AF episodes lasting greater than 6 minutes after AF ablation | As detected by ILR, outside blanking period | 12 months | 
| New MRI-detected subclinical cerebral embolic events |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Persistent atrial fibrillation, Atrial fibrillation ablation