Status:
SUSPENDED
High Intensity Focused Ultrasound (HIFU) Ablation System Study
Lead Sponsor:
ProRhythm, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 wit...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00392106
Start Date
April 1 2006
End Date
June 1 2011
Last Update
June 17 2008
Active Locations (21)
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1
Fullerton Vascular Medical Group
Fullerton, California, United States, 92835
2
University of California, Los Angeles
Los Angeles, California, United States, 90095
3
Piedmont Hospital
Atlanta, Georgia, United States, 30309
4
Lexington Central Baptist Hospital
Lexington, Kentucky, United States, 40503