CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Official Title
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CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Device: Ablation catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must not have undergone a previous ablation for the treatment of PAF AF Type - Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) where PAF is defined as recurrent (two or more) episodes of AF that terminate spontaneously in less than seven days, usually less than 48 hours Exclusion Criteria: Atrial fibrillation secondary to a reversible cause or of non-cardiac origin Diagnosed with persistent atrial fibrillation defined as recurrent episodes lasting more than 7 and less than 365 days More than 4 electrical cardioversions in the year prior to enrollment but not including cardioversions performed within 48 hours of arrhythmia onset Documented left atrial thrombus on imaging Cannot be removed from anti-arrhythmic drugs for other reasons than atrial fibrillation New York Heart Association (NYHA) functional Class III or Class IV heart failure Left ventricular ejection fraction < 30% Left atrial size > 55 mm as measured in the parasternal antero-posterior view Myocardial infarction within 60 days prior to enrolment Woman of childbearing potential who is pregnant, lactating or not using adequate birth control

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HeartLight® EGLA<br>Participants will be treated with the endoscopically guided laser ablation catheter | Device: Ablation catheter<br>* Ablation of paroxysmal atrial fibrillation<br>|
| Active Comparator: Contact Force Sensing Irrigated RF ablation<br>Participants will be treated with a contact force sensing irrigated radiofrequency ablation catheter | Device: Ablation catheter<br>* Ablation of paroxysmal atrial fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from symptomatic, recurrent atrial fibrillation (AF) off of anti-arrhythmic drugs | Recurrent AF is defined as any documented episode of AF lasting more than 30 seconds after a blanking period of 90 days post procedure | 12 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute procedure success | Confirmation of electrical isolation with a circular mapping catheter | 30 minutes post procedure | 
| Procedure and fluoroscopy time | Time will be taken | During procedure | 
| Incidence of peri-procedural complications | E.g. major bleeding requiring intervention, phrenic nerve palsy, pericardial tamponade, thrombo-embolic events, pulmonary vein (PV) -stenosis, atrial-to-esophageal fistula, death | From procedure to 12 months post procedure | 
| Freedom from symptomatic, recurrent Atrial Tachy Arrhythmia (ATA) off of anti-arrhythmic drugs | Recurrent ATA is defined as any documented episode of ATA lasting more than 30 seconds after a blanking period of 90 days post procedure | 12 months post procedure |