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

NeuroTherapia, Inc.

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: PVI then DCC after; Procedure: DCC first then PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT02429648

09-308

Details and patient eligibility

About

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.

Full description

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

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

PVI performed in Normal Sinus Rhythm

Active Comparator group

Description:

DCC first then PVI

Treatment:

Procedure: DCC first then PVI

PVI performed in Atrial Fibrillation

Active Comparator group

Description:

PVI then DCC after if patient remains in Atrial Fibrillation

Treatment:

Procedure: PVI then DCC after