High Intensity Focused Ultrasound (HIFU) Ablation System Study
Information source: ProRhythm, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: propafenone (Drug); flecainide (Drug); dofetilide (Drug); sotolol (Drug); Pulmonary vein ablation (Device); Amiodarone (Drug)
Phase: Phase 3
Status: Suspended
Sponsored by: ProRhythm, Inc. Official(s) and/or principal investigator(s): Warren Jackman, MD, Principal Investigator, Affiliation: Oklahoma University Health Sciences Center Hugh Calkins, MD, Principal Investigator, Affiliation: Johns Hopkins Medical Center
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.
Clinical Details
Official title: Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Acute treatment with elimination of AF episodesDeath, stroke, and hospitalization for recurrence of AF
Secondary outcome: Acute treatment success
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).
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Homolka Hospital, Prague, Czech Republic
Fullerton Vascular Medical Group, Fullerton, California 92835, United States
University of California, Los Angeles, Los Angeles, California 90095, United States
Piedmont Hospital, Atlanta, Georgia 30309, United States
Lexington Central Baptist Hospital, Lexington, Kentucky 40503, United States
Johns Hopkins Hopsital, Baltimore, Maryland 21287, United States
Lahey Clinic, Burlington, Massachusetts 01805, United States
Beaumont Hospital, Royal Oak, Michigan 48220, United States
New York University Hospital, New York, New York 10016, United States
Stony Brook University Hospital, Stony Brook, New York 11794, United States
Wake Forest University Health Systems, Winston Salem, North Carolina 27157, United States
Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States
Hillcrest Hospital, Cleveland, Ohio 44124, United States
The Ohio State University Heart Center, Columbus, Ohio 43210, United States
Oklahoma University Health Sciences Center, Oklahoma City, Oklahoma 73104, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Medical University of South Carolina, Charleston, South Carolina 29425, United States
Texas Cardiac Arrhythmia Research, Austin, Texas 78705, United States
University of Texas, Southwestern, Dallas, Texas 75390, United States
University of Virginia, Charlottesville, Virginia 22903, United States
Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States
Additional Information
Starting date: April 2006
Last updated: June 16, 2008
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