High Intensity Focused Ultrasound (HIFU) Ablation System Study
- Conditions
- Atrial Fibrillation
- Interventions
- Device: Pulmonary vein ablationDrug: sotolol
- Registration Number
- NCT00392106
- Lead Sponsor
- ProRhythm, Inc.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 240
- Documented atrial fibrillation
- Failed or intolerant to at least 1 anti-arrhythmic drug
- Able to take anti-coagulant therapy
- Able to complete screening tests required for inclusion/exclusion criteria
- Able to take at least 1 approved anti-arrhythmic drug
- Not pregnant
- Available for follow-up for at least 12 months
- Persistent or permanent atrial fibrillation
- Mitral disease
- Prior surgical treatment for atrial fibrillation
- Ablation for treatment of atrial fibrillation within 6 months
- Severe left ventricular hypertrophy
- Known untreated coagulopathy
- Unstable angina
- Prior stroke
- Uncontrolled heart failure
- Secondary causes of atrial fibrillation
- Uncorrected hyperthyroidism within 12 months
- Pulmonary embolism within 6 months
- Pneumonia or acute pulmonary disease within 3 months
- Pacemaker/ICD
- High risk for esophageal disease
- Currently enrolled in investigational drug or device study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control propafenone Class I or III anti-arrhythmic drug for the treatment of AF Control flecainide Class I or III anti-arrhythmic drug for the treatment of AF Control dofetilide Class I or III anti-arrhythmic drug for the treatment of AF Control sotolol Class I or III anti-arrhythmic drug for the treatment of AF Control Amiodarone Class I or III anti-arrhythmic drug for the treatment of AF Treatment Pulmonary vein ablation Pulmonary vein ablation with HIFU
- Primary Outcome Measures
Name Time Method Acute treatment with elimination of AF episodes 12 months Death, stroke, and hospitalization for recurrence of AF within 12 months of treatment
- Secondary Outcome Measures
Name Time Method Acute treatment success 60 days
Trial Locations
- Locations (21)
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Lahey Clinic
🇺🇸Burlington, Massachusetts, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Ohio State University Heart Center
🇺🇸Columbus, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Texas, Southwestern
🇺🇸Dallas, Texas, United States
Fullerton Vascular Medical Group
🇺🇸Fullerton, California, United States
Lexington Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Johns Hopkins Hopsital
🇺🇸Baltimore, Maryland, United States
Homolka Hospital
🇨🇿Prague, Czech Republic
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
New York University Hospital
🇺🇸New York, New York, United States
Wake Forest University Health Systems
🇺🇸Winston Salem, North Carolina, United States
Oklahoma University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Texas Cardiac Arrhythmia Research
🇺🇸Austin, Texas, United States
Hillcrest Hospital
🇺🇸Cleveland, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States