Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders: The ACTUAL Study

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is a common but often distressing condition. It can be treated with medications, but these are not always effective or tolerated. Ablation is a well-recognised technique that is recommended for those with symptomatic AF who have failed medical therapy. Ablation can be performed in a number of ways. In percutaneous ablation, ablation is performed via tiny punctures in the skin in the groin. In minimally-invasive thoracoscopic ablation, ablation is performed under general anaesthetic via very small incisions in the chest wall. Because AF can be intermittent, the only reliable way to look for it is with long-term ECG monitoring. A safe and practical way to do this is to use implantable loop recorders (ILRs). In this study, the investigators are trying to see if minimally-invasive thoracoscopic ablation is better than percutaneous ablation, and in turn if they are better than Direct current cardioversion (DCCV), using ILRs to monitor AF.

Official Title
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Atrial Fibrillation After Catheter Versus Thoracoscopic Ablation Using Patient Activated Implantable Loop Recorders

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Implantation of implantable loop recorder
* Procedure: Percutaneous ablation of atrial fibrillation
* Procedure: Surgical ablation of atrial fibrillation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic persistent atrial fibrillation Age over 18 years Informed consent Exclusion Criteria: Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI safe. Patients unable to undergo general anaesthesia for AF ablation. Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery Previous thoracic surgery Participation in a conflicting study 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: Percutaneous ablation<br> | Device: Implantation of implantable loop recorder<br>* An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.<br>Procedure: Percutaneous ablation of atrial fibrillation<br>* Catheter-based percutaneous ablation of atrial fibrillation<br>|
| Active Comparator: Surgical ablation<br> | Device: Implantation of implantable loop recorder<br>* An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.<br>Procedure: Surgical ablation of atrial fibrillation<br>* Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation<br>|
| Active Comparator: DCCV<br>Direct current cardioversion | Device: Implantation of implantable loop recorder<br>* An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in AF burden after ablation | Reduction in proportion of time in atrial fibrillation as detected by an implantable loop recorder | One year | 
| Time to recurrence of persistent AF |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence of atrial fibrillation after ablation | Time to first detected episode of atrial fibrillation after ablation, outside a 3 month blanking period | One year | 
| Time to recurrence of symptomatic atrial fibrillation after ablation | Time to first detected symptomatic episode of atrial fibrillation after ablation, outside a 3 month blanking period | One year | 
| New MRI-detected subclinical cerebral ischaemia |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Ablation, Percutaneous ablation, Minimally-invasive thoracoscopic ablation, Implantable loop recorder