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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091597
First Posted: March 24, 2010
Last Update Posted: March 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johns Hopkins University
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • freedom from atrial fibrillation [ Time Frame: 3 months following ablation ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091597


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

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
First Submitted: March 23, 2010
First Posted: March 24, 2010
Last Update Posted: March 24, 2010
Last Verified: March 2010

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