Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jun 2007
Shorter than P25 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedMarch 24, 2010
March 1, 2010
1.7 years
March 23, 2010
March 23, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
freedom from atrial fibrillation
3 months following ablation
Secondary Outcomes (1)
safety of Box isolation
3 months following procedure
Study Arms (2)
usual ablation
ACTIVE COMPARATORWide-area circumferential ablation of the pulmonary veins
Box isolation of the pulmonary veins
EXPERIMENTALSingle Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.
Interventions
Eligibility Criteria
You may qualify if:
- Patients undergoing clinically indicated pulmonary vein ablation for atrial fibrillation.
You may not qualify if:
- Unable to understand consent form. Not scheduled for clinically indicated pulmonary vein ablation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Related Publications (1)
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.
PMID: 21614530DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 23, 2010
First Posted
March 24, 2010
Study Start
June 1, 2007
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
March 24, 2010
Record last verified: 2010-03