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

NCT ID: NCT01091597

Last Updated: 2010-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-02-28

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.

Conditions

Atrial Fibrillation; Radiofrequency Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

usual ablation

Wide-area circumferential ablation of the pulmonary veins

Group Type: ACTIVE_COMPARATOR

usual PV ablation

Intervention Type: PROCEDURE

usual PV ablation, per above

Box isolation of the pulmonary veins

Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.

Group Type: EXPERIMENTAL

Box isolation of pulmonary veins

Intervention Type: PROCEDURE

as above

Interventions

usual PV ablation

usual PV ablation, per above

Intervention Type: PROCEDURE

Box isolation of pulmonary veins

as above

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

Chilukuri K, Scherr D, Dalal D, Cheng A, Spragg D, Nazarian S, Barcelon BD, Marine JE, Calkins H, Henrikson CA. Conventional pulmonary vein isolation compared with the "box isolation" method: a randomized clinical trial. J Interv Card Electrophysiol. 2011 Nov;32(2):137-46. doi: 10.1007/s10840-011-9587-8. Epub 2011 May 26.

Reference Type: DERIVED

PMID: 21614530 (View on PubMed)

Other Identifiers

NA_00008424

Identifier Type: -

Identifier Source: org_study_id