Study Stopped
voluntarily by Sponsor to investigate an anticipated SAE
High Intensity Focused Ultrasound (HIFU) Ablation System Study
Study of Focused Circumferential UltraSound for the Treatment of Atrial Fibrillation
2 other identifiers
interventional
240
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Apr 2006
Longer than P75 for phase_3 atrial-fibrillation
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 24, 2006
CompletedFirst Posted
Study publicly available on registry
October 25, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 17, 2008
June 1, 2008
4.7 years
October 24, 2006
June 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Acute treatment with elimination of AF episodes
12 months
Death, stroke, and hospitalization for recurrence of AF
within 12 months of treatment
Secondary Outcomes (1)
Acute treatment success
60 days
Study Arms (2)
Control
ACTIVE COMPARATORClass I or III anti-arrhythmic drug for the treatment of AF
Treatment
EXPERIMENTALPulmonary vein ablation with HIFU
Interventions
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Anti-arrhythmic drug prescribed for the treatment of Atrial fibrillation
Anti-arrhythmic drug prescribed for treatment of atrial fibrillation
Anti-arrhythmic Drug prescribed for treatment of Atrial Fibrillation
Electrical isolation of pulmonary vein with high-intensity focused ultrasound
Anti-arrhythmic Drug prescribed for the treatment of Atrial Fibrillation
Eligibility Criteria
You may qualify if:
- Documented atrial fibrillation
- Failed or intolerant to at least 1 anti-arrhythmic drug
- Able to take anti-coagulant therapy
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ProRhythm, Inc.lead
Study Sites (21)
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
Hillcrest Hospital
Cleveland, Ohio, 44124, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, 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
Homolka Hospital
Prague, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Warren Jackman, MD
Oklahoma University Health Sciences Center
- PRINCIPAL INVESTIGATOR
Hugh Calkins, MD
Johns Hopkins Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 24, 2006
First Posted
October 25, 2006
Study Start
April 1, 2006
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
June 17, 2008
Record last verified: 2008-06