Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Primary Purpose
Atrial Fibrillation, Radiofrequency Ablation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
usual PV ablation
Box isolation of pulmonary veins
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
usual ablation
Box isolation of the pulmonary veins
Arm Description
Wide-area circumferential ablation of the pulmonary veins
Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.
Outcomes
Primary Outcome Measures
freedom from atrial fibrillation
Secondary Outcome Measures
safety of Box isolation
Full Information
NCT ID
NCT01091597
First Posted
March 23, 2010
Last Updated
March 23, 2010
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01091597
Brief Title
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Official Title
PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Radiofrequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual ablation
Arm Type
Active Comparator
Arm Description
Wide-area circumferential ablation of the pulmonary veins
Arm Title
Box isolation of the pulmonary veins
Arm Type
Experimental
Arm Description
Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.
Intervention Type
Procedure
Intervention Name(s)
usual PV ablation
Intervention Description
usual PV ablation, per above
Intervention Type
Procedure
Intervention Name(s)
Box isolation of pulmonary veins
Intervention Description
as above
Primary Outcome Measure Information:
Title
freedom from atrial fibrillation
Time Frame
3 months following ablation
Secondary Outcome Measure Information:
Title
safety of Box isolation
Time Frame
3 months following procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21614530
Citation
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.
Results Reference
derived
Learn more about this trial
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
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