Randomized Trial of Two Ablation Catheters in Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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Atrial fibrillation (AF) is a chaotic heart rhythm of the top chambers of the heart. AF occurs in up to 10% of the population over the age of 60. It is associated with tiredness, impaired functional capacity and is the cause of up to 10% of strokes. Ablation is a procedure performed with small tubes (catheters) that are introduced through the top of the leg. Burns are made inside of the heart to treat AF. This procedure has been shown to cure 90% of patients with intermittent (paroxysmal) AF. The investigators currently use either one of two different catheters to create these burns inside the heart. The investigators do not know which is the best catheter to use in patients with paroxysmal atrial fibrillation. The investigators study will randomly allocate patients to have their ablation performed by either one of the catheters to give a fair comparison between the two. The investigators objective is to study the differences between these two catheters.

Official Title
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A Single Centre, Randomized, Single Blinded Trial of Wide Area Circumferential Ablation With Pulmonary Vein Isolation Compared to a Multipolar, Circular Ablation Catheter in Patients With Paroxysmal Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: WACA and PVI
* Device: PVAC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with paroxysmal AF with a planned ablation procedure Exclusion Criteria: Prior AF ablation LA size greater than 60mm Mechanical prosthetic MVR Hypertrophic cardiomyopathy

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>WACA and PVI | Device: WACA and PVI<br>* Wide area circumferential ablation (WACA) in the pulmonary vein antrum with subsequent pulmonary vein isolation (PVI) with a single tip irrigated catheter.<br>|
| Active Comparator: 2<br>PVAC | Device: PVAC<br>* Circumferential ablation with a circular ablation catheter (Ablation Frontiers) to electrical silence.<br>* Other names: Pulmonary vein ablation catheter, Ablation Frontiers;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom of AF at 1 year following AF ablation procedure measured by 7 day holter recording |  | 1 year | 
| Procedural time for pulmonary vein isolation |  | Index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All procedural complications |  | Index | 
| Incidence of pulmonary vein stenosis measure by MRI at 6 months post procedure |  | 6 months | 
| Quality of life questionnaire |  | 6 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized Controlled Trial, Single-Blind Study, Catheter Ablation