Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Radiofrequency Ablation
• Interventions: Procedure: usual PV ablation; Procedure: Box isolation of pulmonary veins

• Registration Number: NCT01091597
• Lead Sponsor: Johns Hopkins University

Brief Summary

Curative catheter ablation has been established as an effective therapeutic option for atrial fibrillation (AF) that is resistant to pharmacologic rhythm or rate control. However, standard ablative approaches targeting the pulmonary veins (PVs) are associated with a success rate as low as 40%. In a recent study, Kumagai et al. described a new approach of catheter ablation of AF isolating the posterior left atrium including all PVs (called Box Isolation). In Kumagai's study, 46 patients with symptomatic AF underwent box isolation. At 6 months follow up, 43 of 46 patients (93%) were arrhythmia free without antiarrhythmic drugs, with a single procedure success rate of 87% (40/46). This study provided new evidence supporting the hypothesis that the posterior wall is of high importance for the maintenance of AF. The aim of the investigators study is to determine the efficacy of two different approaches of catheter ablation (Standard PV Isolation vs. Box isolation) for the treatment of chronic AF.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-03
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-23
• Last Update Submitted: 2010-03-23
• Study First Posted: 2010-03-24
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.

Exclusion Criteria

• Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual ablation	usual PV ablation	Wide-area circumferential ablation of the pulmonary veins
Box isolation of the pulmonary veins	Box isolation of pulmonary veins	Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.

Primary Outcome Measures

Name	Time	Method
freedom from atrial fibrillation	3 months following ablation

Secondary Outcome Measures

Name	Time	Method
safety of Box isolation	3 months following procedure

Trial Locations

Locations (1)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States