Status:
COMPLETED
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Lead Sponsor:
CardioFocus
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by cre...
Detailed Description
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
Eligibility Criteria
Inclusion
- 18 to 75 years.
- paroxysmal atrial fibrillation
- failure of at least one AAD
- others
Exclusion
- overall good health as established by multiple criteria
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
405 Patients enrolled
Trial Details
Trial ID
NCT01456000
Start Date
January 1 2012
End Date
January 1 2016
Last Update
September 8 2016
Active Locations (21)
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1
University of Alabama, Birmingham
Birminham, Alabama, United States
2
Stanford Hospital
Palo Alto, California, United States, 94305
3
Regional Cardiology Associates, Mercy General Hospital
Sacramento, California, United States, 95819
4
UCSF
San Francisco, California, United States, 94143