Timing of Direct Current Cardioversion (DCC) in Patients Undergoing Ablation of Persistent/Permanent Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to compare which strategy is superior in patients with persistent/permanent atrial fibrillation (AF) undergoing ablation, direct current cardioversion (DCC) prior to empirical pulmonary vein isolation (PVI) ; or pulmonary vein isolation (PVI)ablation in atrial fibrillation then Direct current cardioversion (DCC) if the patient remains in atrial fibrillation.

Detailed Description
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Ablation of persistent/permanent Atrial Fibrillation (AF) remains a challenge. There are several strategies to improve the outcomes of persistent/permanent AF ablation. At the Cleveland Clinic one of the commonly used strategies is Direct Current Cardioversion (DCC). Depending on physician preference, patients may be ablated in atrial fibrillation then Direct current cardioverted; or Direct current cardioverted and ablated in sinus rhythm. Neither approach has been shown to be superior. As both approaches are currently being performed based on physician preference, the investigators propose to study and compare both approaches in a randomized fashion for evidence based practice. The purpose of this study is to compare which standard of care strategy is superior in patients with persistent/permanent Atrial Fibrillation undergoing ablation, direct current cardioversion prior to empirical pulmonary vein isolation; or ablation in atrial fibrillation then direct current cardioversion if the patient remains in atrial fibrillation

Official Title
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Timing of DCC in Patients Undergoing Pulmonary Vein Isolation Ablation (PVI) of Persistent/Permanent Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: DCC first then PVI
* Procedure: PVI then DCC after


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent or long standing persistent AF resistant to anti-arrhythmic medication. Must have been present for more than 2 months Therapeutic anticoagulation for at least three weeks prior to initiation of therapy, or TEE performed prior to the procedure Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control Scheduled for Pulmonary Vein Isolation Amiodarone will be stopped at least 3 months prior to procedure Exclusion Criteria: Reversible causes of AF such as pericarditis, hyperthyroidism Presently with Valvular Heart disease requiring surgical intervention Presently with coronary artery disease requiring surgical intervention Early Post-operative AF (within three months of surgery) Previous MAZE or left atrial instrumentation Life expectancy <= 2 years Social factors that would preclude follow up or make compliance difficult. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin Enrollment in another investigational drug or device study Patients with severe pulmonary disease Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI performed in Normal Sinus Rhythm<br>DCC first then PVI | Procedure: DCC first then PVI<br>* DCC performed prior to PVI<br>|
| Active Comparator: PVI performed in Atrial Fibrillation<br>PVI then DCC after if patient remains in Atrial Fibrillation | Procedure: PVI then DCC after<br>* DCC performed after PVI, if patient remains in Atrial Fibrillation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of procedure |  | day of procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of duration of fluoroscopy, and radiation exposure doses |  | day of procedure | 
| Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG |  | 12 months | 
| frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF