Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
ProRhythm, Inc. |
---|---|
Information provided by: | ProRhythm, Inc. |
ClinicalTrials.gov Identifier: | NCT00392106 |
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).
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Warren Jackman, MD | Oklahoma University Health Sciences Center |
Principal Investigator: | Hugh Calkins, MD | Johns Hopkins Medical Center |
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 Propafenone Heart Diseases Potassium Channel Blockers Flecainide Dofetilide |
Cardiovascular Agents Anti-Arrhythmia Agents Atrial Fibrillation Amiodarone Sotalol Arrhythmias, Cardiac |
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 |