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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COMPLETED
NA
174 participants
INTERVENTIONAL
2004-11-30
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment with CryoCor Cryoablation System
Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF.
Cardiac CryoCor Cryoablation System
Treatment with CryoCor Cardiac Cryoablation system
Treatment with standard medical therapy
Intervention includes treatment with ant-arrhythmic medications alone.
Medical management
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Interventions
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Cardiac CryoCor Cryoablation System
Treatment with CryoCor Cardiac Cryoablation system
Medical management
Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Refractory to at least one drug
* Therapeutic anticoagulation
* Signed informed consent
Exclusion Criteria
* Structural heart disease
* Prior ablation
* Contraindication present
18 Years
75 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Feld, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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Regional Cardiology Associates
Sacramento, California, United States
UCSD Medical Center
San Diego, California, United States
UCSF Medical
San Francisco, California, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago Hospitals
Chicago, Illinois, United States
Carle Heart Center
Urbana, Illinois, United States
Genesis Health
Davenport, Iowa, United States
Iowa Heart Center
Des Moines, Iowa, United States
Cardiology Associates of Kentucky
Lexington, Kentucky, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
St. Luke's-Roosevelt Hospital Center
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Heart and Vascular Institute
Hershey, Pennsylvania, United States
Drexel University
Philadelphia, Pennsylvania, United States
Austin Heart, PA
Austin, Texas, United States
Methodist Debakey Heart Center
Houston, Texas, United States
Tacoma General
Tacoma, Washington, United States
Heart Care Associates
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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GL-AF-02
Identifier Type: -
Identifier Source: org_study_id
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