Atrial Fibrillation Force Contact Ablation Study

Study Overview
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Brief Summary
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This study will be divided into two phases. The purpose of the Phase I registry is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data. In Phase II of the study, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the THERMOCOOL® SMARTTOUCH™ catheter.

Detailed Description
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Atrial fibrillation (AF) is the most common arrhythmia affecting over 5% of the population above the age of 65 years. The use of percutaneous catheter ablation for symptomatic management has increased over the last decade. It is well established that AF ablation is superior to anti-arrhythmic drugs for symptomatic recurrence of AF. Despite this, success rates with a single procedure for paroxysmal AF is approximately 80% with the majority of recurrence due to recovery of lesions or gaps found at repeat procedures. In this study, patients with symptomatic paroxysmal atrial fibrillation (AF) will undergo ablation using a newly Health Canada approved catheter with SmartTouch technology that enables the measurement of catheter tip contact force and direction inside the heart. The purpose of Phase I of the study is to assess the current force being used for ablation of symptomatic paroxysmal AF in a wide range of operators in different Canadian centres with the operators being blinded to the contact force data. The secondary objective will be to assess whether lesion recovery, as assessed in redo procedures, corresponds to contact force measurements. It is hypothesized that gaps found on repeat procedures will correspond to ablation lesions associated with a lower contact force. In Phase II, operators will have open use of the force contact data. Phase I and II data will be compared in order to assess the efficiency of using the SmartTouch catheter. It is hypothesized that the open use of contact force data will decrease the procedural time and number of lesions to achieve bidirectional pulmonary vein isolation.

Official Title
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The Canadian Atrial Fibrillation Force Contact Ablation Study

Conditions
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Paroxysmal Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years or greater. Patients undergoing first-time pulmonary vein catheter ablation for AF. Patients with paroxysmal AF. Paroxysmal AF will be defined as symptomatic episodes of AF lasting less than 7 days or treated with cardioversion(s) within 48 hours of onset. At least one episode of AF must have been documented on telemetry, ambulatory monitor, or 12-lead ECG. Patients must be able and willing to provide written informed consent to participate in the clinical study. Exclusion Criteria: Patients with a history of any previous ablation for atrial fibrillation. Patients with a previous atriotomy scar, ie. Mitral or tricuspid valve replacement or repair, ASD surgery, cardiac transplant. Patients with an intracardiac thrombus Patients who are or may potentially be pregnant.

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operator Blinded to Contact Force<br>Physicians performing the ablation will be blinded to the contact force data | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Time | Length of time between first ablation and last ablation | participants will be followed for the duration of hospital stay, an expected average of 36 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion Recovery | Localization of recovered gaps | up to 1 year | 
| Ablation Time | Total time of ablation used during procedure | participants will be followed for the duration of hospital stay, an expected average of 36 hours | 
| Number of ablation lesions | Total number of ablation lesions to achieve bidirectional block of all 4 pulmonary veins | participants will be followed for the duration of hospital stay, an expected average of 36 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Catheter Ablation, Electrophysiology, Cardiac Arrhythmias