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Sponsored by: |
Ablation Frontiers |
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Information provided by: | Ablation Frontiers |
ClinicalTrials.gov Identifier: | NCT00514735 |
The purpose of the trial is to evaluate the safety and efficacy of the Ablation Frontiers Cardiac Ablation System compared to currently approved treatment options for atrial fibrillation.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation |
Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Tailored Treatment of Permanent Atrial Fibrillation - TTOP AF |
Estimated Enrollment: | 210 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Ablation Management
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Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator)
Ablation procedures and/or DC Cardioversions
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2: Active Comparator
Medical Management
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Procedure: Ablation Frontiers Cardiac Ablation System (Arm 1- Experimental); DC Cardioversions (Arm 2- Active Comparator)
Ablation procedures and/or DC Cardioversions
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Ablation Frontiers, Inc. ( Jerald Cox, Director of Clinical Affairs ) |
Study ID Numbers: | AFI-30 |
Study First Received: | August 8, 2007 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00514735 |
Health Authority: | United States: Food and Drug Administration |
atrial fibrillation |
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |