High Intensity Focused Ultrasound (HIFU) Ablation System Study
NCT ID: NCT00392106
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
PHASE3
240 participants
INTERVENTIONAL
2006-04-30
2011-06-30
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control
Class I or III anti-arrhythmic drug for the treatment of AF
propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
Treatment
Pulmonary vein ablation with HIFU
Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
Interventions
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propafenone
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
flecainide
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
dofetilide
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
sotolol
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Pulmonary vein ablation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
Amiodarone
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Failed or intolerant to at least 1 anti-arrhythmic drug
* Able to take anti-coagulant therapy
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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ProRhythm, Inc.
INDUSTRY
Responsible Party
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ProRhythm, Inc.
Principal Investigators
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Warren Jackman, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma University Health Sciences Center
Hugh Calkins, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins Medical Center
Locations
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Fullerton Vascular Medical Group
Fullerton, California, United States
University of California, Los Angeles
Los Angeles, California, United States
Piedmont Hospital
Atlanta, Georgia, United States
Lexington Central Baptist Hospital
Lexington, Kentucky, United States
Johns Hopkins Hopsital
Baltimore, Maryland, United States
Lahey Clinic
Burlington, Massachusetts, United States
Beaumont Hospital
Royal Oak, Michigan, United States
New York University Hospital
New York, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Wake Forest University Health Systems
Winston-Salem, North Carolina, United States
Hillcrest Hospital
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University Heart Center
Columbus, Ohio, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
University of Texas, Southwestern
Dallas, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Homolka Hospital
Prague, , Czechia
University of Virginia
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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NCT00392106
Identifier Type: -
Identifier Source: secondary_id
CLIN-003
Identifier Type: -
Identifier Source: org_study_id