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

Atrial Fibrillation Clinical Trial

Official title:

PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091597
• Other study ID #: NA_00008424
• Status: Completed
• Phase: N/A
• First received: March 23, 2010
• Last updated: March 23, 2010
• Start date: June 2007
• Est. completion date: February 2009

Study information

• Verified date: March 2010
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Radiofrequency Ablation

Intervention

Procedure:
• usual PV ablation
usual PV ablation, per above
• Box isolation of pulmonary veins
as above

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	freedom from atrial fibrillation		3 months following ablation	No
Secondary	safety of Box isolation		3 months following procedure	Yes