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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01091597
First received: March 23, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Radiofrequency Ablation
 Procedure: usual PV ablation
Procedure: Box isolation of pulmonary veins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • freedom from atrial fibrillation [ Time Frame: 3 months following ablation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of Box isolation [ Time Frame: 3 months following procedure ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: usual ablation
Wide-area circumferential ablation of the pulmonary veins
 Procedure: usual PV ablation
usual PV ablation, per above
Experimental: Box isolation of the pulmonary veins
Single Box lesion set encompassing all four pulmonary veins and the posterior wall of the left atrium.
 Procedure: Box isolation of pulmonary veins
as above

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091597

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Charles Henrikson, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01091597     History of Changes
Other Study ID Numbers: NA_00008424
Study First Received: March 23, 2010
Last Updated: March 23, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013