- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091597
Pulmonary Vein (PV) Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
March 23, 2010 updated by: Johns Hopkins University
PV Isolation Versus Box Isolation for the Treatment of Atrial Fibrillation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: usual ablation
Wide-area circumferential ablation of the pulmonary veins
|
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.
|
as above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
freedom from atrial fibrillation
Time Frame: 3 months following ablation
|
3 months following ablation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
safety of Box isolation
Time Frame: 3 months following procedure
|
3 months following procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 23, 2010
First Posted (Estimate)
March 24, 2010
Study Record Updates
Last Update Posted (Estimate)
March 24, 2010
Last Update Submitted That Met QC Criteria
March 23, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00008424
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on usual PV ablation
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