Study of HD Mesh Ablation System for Treatment of Paroxysmal Atrial Fibrillation
NCT ID: NCT00741611
Last Updated: 2012-10-26
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
44 participants
INTERVENTIONAL
2008-07-31
2009-11-30
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
SINGLE
Study Groups
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Mesh
Ablation with HD Mesh Ablation System
HD Mesh Ablation System
Ablation using the HD Mesh Ablation System
Drug
Treatment with anti-arrhythmic drugs
Anti-arrhythmic drugs
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Interventions
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HD Mesh Ablation System
Ablation using the HD Mesh Ablation System
Anti-arrhythmic drugs
5 anti-arrhythmic drugs administered at the labeled dosage for atrial fibrillation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Permanent AF
* Uncontrolled or unstable medical conditions
21 Years
75 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Anne Marie Harcarik
Role: STUDY_DIRECTOR
C. R. Bard, Inc.
Locations
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University of California, San Diego Medical Center
San Diego, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
Mayo Clinic
Jacksonville, Florida, United States
Florida Heart Group
Orlando, Florida, United States
Bay Heart Group
Tampa, Florida, United States
Piedmont Hospital Research Institute
Atlanta, Georgia, United States
Northeast Cardiology Associates
Bangor, Maine, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
St. John's Medical Research Institute
Springfield, Missouri, United States
Lehigh Valley Heart Specialists
Allentown, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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Other Identifiers
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IDE # G070179
Identifier Type: -
Identifier Source: secondary_id
BEP-4408-2007
Identifier Type: -
Identifier Source: org_study_id