Catheter Evaluation for Endocardial Ablation in Patients With Typical Atrial Flutter
NCT ID: NCT00318565
Last Updated: 2012-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
291 participants
INTERVENTIONAL
2006-01-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Navistar ThermoCool Catheter
RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Interventions
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RF energy delivery for treatment of Typical Atrial flutter
Navistar ThermoCool catheter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by 12 lead electrocardiogram (ECG), Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device within 6 months prior to enrollment.
* 18 years of age or older
* Informed consent
Exclusion Criteria
* Uncontrolled heart failure, or New York Heart Association (NYHA) class III or IV heart failure
* Women who are pregnant
* Cardiac surgery (ventriculotomy or atriotomy) within the past two months
* Intra-atrial thrombus, tumor, or other abnormality that precludes catheter introduction and placement
* Unstable angina or acute myocardial infarction within 3 months
* Awaiting cardiac transplantation
* Heart disease in which corrective surgery is anticipated within 6 months
* Presence of condition that precludes appropriate vascular access
* Enrolled in any investigational device exemption (IDE) investigating study for a device or drug
* High risk for non-compliance with the protocol (e.g., inaccessible for follow-up by the investigator or patient's physician)
* Radio frequency (RF) ablation for typical atrial flutter within the past 2 months
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Warren Jackman, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Alabama, Birmingham
Birmingham, Alabama, United States
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Good Samaritan Hospital
Los Angeles, California, United States
Pacific Heart Institute
Santa Monica, California, United States
University of Florida
Gainsville, Florida, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Florida Hospital
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
The Care Group LLC, St. Vincent Hospital and Health Care Center, Inc.
Indianapolis, Indiana, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Park Nicollet Institute
Minneapolis, Minnesota, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Oklahoma, Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Heart Institute
Houston, Texas, United States
University of Vermont, College of Medicine
Burlington, Vermont, United States
INOVA Research Center
Falls Church, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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BWI30031
Identifier Type: -
Identifier Source: org_study_id
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