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

The Cleveland Clinic90 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

DCC first then PVIPROCEDURE

DCC performed prior to PVI

PVI then DCC afterPROCEDURE

DCC performed after PVI, if patient remains in Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Duration of procedure

Time frame: day of procedure

Secondary Outcomes

Composite of duration of fluoroscopy, and radiation exposure doses

Time frame: day of procedure

Composite of AT/AF burden and total frequency measured by event monitor, holter and/or EKG

Time frame: 12 months

frequency of symptomatic atrial arrhythmias measured by event monitor, holter, and/or EKG

Time frame: 12 months

Data from ClinicalTrials.gov

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