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| Sponsor: | ProRhythm, Inc. |
|---|---|
| Information provided by: | ProRhythm, Inc. |
| ClinicalTrials.gov Identifier: | NCT00392106 |
Purpose
The purpose of this study is to determine if the HIFU Pulmonary Vein Ablation System is effective in the treatment of paroxysmal Atrial Fibrillation compared to the control of best medical therapy with FDA approved antiarrhythmic drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: propafenone Drug: flecainide Drug: dofetilide Drug: sotolol Device: Pulmonary vein ablation Drug: Amiodarone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation |
| Estimated Enrollment: | 240 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Control: Active Comparator
Class I or III anti-arrhythmic drug for the treatment of AF
|
Drug: propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Drug: flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
Drug: dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Drug: sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Drug: Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
|
|
Treatment: Experimental
Pulmonary vein ablation with HIFU
|
Device: Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
|
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia affecting an estimated 2.2 million persons in the United States (US). In addition to being debilitating, AF has been identified as a leading risk factor for stroke. AF is often associated with structural heart disease, but a substantial number of AF patients have little or no detectable structural heart disease. A patient with AF is up to 5 times more likely to have a stroke than the general population.
Recently, it has been demonstrated that for a significant portion of AF patients (80% - 95 %) the arrhythmia originates in one of the four pulmonary veins (PV's). Furthermore, it has been shown that isolation of this arrhythmia by ablation can, in the majority of patients (50-70%), eliminate or markedly reduce episodes of AF. Currently, there are a number of modalities being investigated to treat AF. They include radiofrequency, laser, thermal, cryo, microwave, and ultrasound ablation of targeted areas in the atrium and/or PVs.
Comparison(s): Clinical success of High Intensity Focused Ultrasound (HIFU) Ablation for Pulmonary Vein Isolation in the treatment of Atrial Fibrillation, compared to medical therapy with anti-arrhythmic drugs (AADs).
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, California | |
| University of California, Los Angeles | |
| Los Angeles, California, United States, 90095 | |
| Fullerton Vascular Medical Group | |
| Fullerton, California, United States, 92835 | |
| United States, Georgia | |
| Piedmont Hospital | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Kentucky | |
| Lexington Central Baptist Hospital | |
| Lexington, Kentucky, United States, 40503 | |
| United States, Maryland | |
| Johns Hopkins Hopsital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Lahey Clinic | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, Michigan | |
| Beaumont Hospital | |
| Royal Oak, Michigan, United States, 48220 | |
| United States, New York | |
| New York University Hospital | |
| New York, New York, United States, 10016 | |
| Stony Brook University Hospital | |
| Stony Brook, New York, United States, 11794 | |
| United States, North Carolina | |
| Wake Forest University Health Systems | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| The Ohio State University Heart Center | |
| Columbus, Ohio, United States, 43210 | |
| Hillcrest Hospital | |
| Cleveland, Ohio, United States, 44124 | |
| United States, Oklahoma | |
| Oklahoma University Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research | |
| Austin, Texas, United States, 78705 | |
| University of Texas, Southwestern | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Sentara Norfolk General Hospital | |
| Norfolk, Virginia, United States, 23507 | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22903 | |
| Czech Republic | |
| Homolka Hospital | |
| Prague, Czech Republic | |
| Principal Investigator: | Warren Jackman, MD | Oklahoma University Health Sciences Center |
| Principal Investigator: | Hugh Calkins, MD | Johns Hopkins Medical Center |
More Information
| Responsible Party: | ProRhythm, Inc. ( Reinhard Warnking, President and CEO ) |
| Study ID Numbers: | CLIN-003, NCT00392106 |
| Study First Received: | October 24, 2006 |
| Last Updated: | June 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00392106 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
atrial fibrillation arrhythmia AF ablation |
antiarrhythmic agent catheter ablation pulmonary veins |
|
Vasodilator Agents Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone Pharmacologic Actions Membrane Transport Modulators Pathologic Processes |
Propafenone Therapeutic Uses Potassium Channel Blockers Dofetilide Flecainide Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |
