Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs
NCT ID: NCT00477230
Last Updated: 2012-06-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
64 participants
INTERVENTIONAL
2007-03-31
2009-05-31
Brief Summary
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* A single catheter ablation procedure with the investigational EAS, a visually-guided, light-energy catheter
* Standard drug therapy (antiarrhythmic drugs)
To learn more about the CardioFocus ENABLE investigational clinical study, please contact the study site closest to you.
Eligibility Criteria
Persons with paroxysmal atrial fibrillation may be eligible for this study. Other study eligibility criteria include:
* 18 to 80 years of age
* Frequent episodes of AF
* Failed at least 1 drug treatment for AF (beta-blockers or standard AADs)
* Other criteria
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
Single ablation procedure with Endoscopic Ablation System
Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
2
Medication
Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.
Interventions
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Endoscopic Ablation System
Single ablation procedure with Endoscopic Ablation System
Standard Anti-arrhythmic Drug (AAD) Therapy
Medication as prescribed by physician.
Eligibility Criteria
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Inclusion Criteria
* Paroxysmal atrial fibrillation (AF)
* Frequent episodes of AF
* Failed at least 1 drug treatment
* Others
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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CardioFocus
INDUSTRY
Responsible Party
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Principal Investigators
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Vivek Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Andrea Natale, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Cardiac Arrhythmia
Burke Barrett
Role: STUDY_DIRECTOR
CardioFocus, Inc.
Locations
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Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States
Mercy General Hospital
Sacramento, California, United States
University of California at San Francisco
San Francisco, California, United States
St. John's Health Center
Santa Monica, California, United States
Palm Beach Heart Research Institute
Atlantis, Florida, United States
Florida Hospital
Orlando, Florida, United States
Indiana University, Krannert Institute of Cardiology
Indianapolis, Indiana, United States
Genesis Medical Center
Davenport, Iowa, United States
University of Michigan
Ann Arbor, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
St. Luke's-Roosevelt
New York, New York, United States
Strong Memorial Hosptial - University of Rochester
Rochester, New York, United States
Ohio State University
Columbus, Ohio, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Countries
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Other Identifiers
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ENABLE 25-2064
Identifier Type: -
Identifier Source: org_study_id
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