Eagle AF (Atrial Fibrillation) - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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The study aims to compare the results of pulmonary vein isolation (PVI) with a single technology approach in patients suffering from paroxysmal atrial fibrillation (PAF) with patients who have persistent AF of less than 3 months. Many studies have shown that electrical reconnection of the pulmonary veins following the index procedure can occur in up to 40% of targeted veins leading to a recurrence of PAF. Endoscopically guided laser ablation utilising the HeartLight system (CardioFocus Inc., USA) has been shown to be safe and effective and has also shown promising rates of durable isolation compared to point by point radio frequency techniques. However, the impact of employing this technique for patients with persistent AF has not yet been reported. The study hypothesis is that there will be no statistically significant difference between the results of PVI in the two groups of patients.

Official Title
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Eagle AF - Endoscopically Guided Laser Ablation of Persistent Atrial Fibrillation

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Device: Endoscopically guided laser ablation HeartLight system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: failure of at least one specific class I or III antiarrhythmic drug (AAD) left atrial size < 50 mm left ventricular ejection fraction > 45% others specific for PAF: diagnosed with self-terminating episodes for no longer than 7 days specific for persistent AF: diagnosed with episodes of > 7 days and < 90 days Exclusion Criteria: AF secondary to a reversible cause of non-cardiac origin uncontrollable hypertension left atrial thrombus others specific for PAF: more than 1 electrical cardioversion in the year prior to enrollment specific for persistent AF more than 4 electrical cardioversions in the year prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paroxysmal Atrial Fibrillation (PAF)<br>Endoscopically guided laser ablation | Device: Endoscopically guided laser ablation HeartLight system<br> <br> * Other names: HeartLight system;|
| Active Comparator: Persistent Atrial Fibrillation<br>Endoscopically guided laser ablation | Device: Endoscopically guided laser ablation HeartLight system<br> <br> * Other names: HeartLight system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documented recurrence of AF or any tachyarrhythmia lasting > 30 seconds |  | Between day 90 and 365 after index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of electrical cardioversions needed |  | 365 days after index procedure |