Guidant Microwave Ablation System for the Treatment of Atrial Fibrillation
NCT ID: NCT00111488
Last Updated: 2016-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
200 participants
INTERVENTIONAL
2005-06-30
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Interventions
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Flex 4 and Generator
Eligibility Criteria
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Inclusion Criteria
* Documented permanent AF (for at least three months)
* Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
* Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
Exclusion Criteria
* Myocardial infarction within the previous 6 weeks
* Documented history of pulmonary vein stenosis
* Previous ablation attempt for AF
* Previous thoracic procedures
* Left atrial size \> 7.0 cm
* Left ventricular ejection fraction \< 30%
* Presence of left atrial or left atrial appendage thrombi
* Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
* Known allergy or contraindication to warfarin therapy
* Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
* Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
* Geographically remote or unable to return for follow-up examinations
* Pregnant or planning to become pregnant during the study
* Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Mack, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiopulmonary Research Science and Technology Institute
Locations
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Scripps Memorial/ Kaiser Permanente
La Jolla, California, United States
Long Beach Memorial Medical Center
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Mercy General Hospital
Sacramento, California, United States
Piedmont Hospital
Atlanta, Georgia, United States
Methodist Hospital
Indianapolis, Indiana, United States
St. Francis Hospital and Health Center
Indianapolis, Indiana, United States
Alegent Health
Omaha, Nebraska, United States
St. Michael's Medical Center
Newark, New Jersey, United States
Valley Hospital
Ridgewood, New Jersey, United States
Lenox Hill Hospital
New York, New York, United States
Univesity of Rochester Medical
Rochester, New York, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Cardiopulmonary Research Science and Technology Institute
Dallas, Texas, United States
Baylor University
Dallas, Texas, United States
Plaza Medical Center
Fort Worth, Texas, United States
University of VIrginia Health System
Charlottesville, Virginia, United States
Virginia Masonic Clinic
Seattle, Washington, United States
Wisconsin Heart Hospital
Milwaukee, Wisconsin, United States
Wausau Heart and Lung Surgeons
Wausau, Wisconsin, United States
Countries
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Other Identifiers
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VR2045885
Identifier Type: -
Identifier Source: org_study_id
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