Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
- Conditions
- Paroxysmal Atrial Fibrillation
- Registration Number
- NCT00971204
- Lead Sponsor
- CardioFocus
- Brief Summary
This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation in the treatment of paroxysmal atrial fibrillation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 18 to 70 years
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
- overall good health as established by multiple criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Freedom From Recurrence of Atrial Fibrillation 12 months Absence of symptomatic atrial fibrillation lasting one minute or more beyond the 90-day blanking period during the 12 month evaluation period.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Pacific Heart Institute
🇺🇸Santa Monica, California, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States
The Methodist Hospital Research Institute
🇺🇸Houston, Texas, United States
University Of Virginia Health System
🇺🇸Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
🇺🇸Norfolk, Virginia, United States
University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States