NCT03168659NARecruiting
CardioFocus HeartLight Post-Approval Study
CardioFocus
Start Date
6/16/2017
Completion Date
10/1/2028
Summary
This is a post-approval study to evaluate the clinical outcomes in a cohort of participants treated during commercial use of the HeartLight System to confirm results of the previously conducted pivotal clinical study.
Detailed Description
This is a prospective, open-label, multi-center, single arm study designed to assess continued safety and effectiveness of the HeartLight System during commercial use in participants being treated for drug refractory, symptomatic, paroxysmal atrial fibrillation.
Eligibility Criteria
Age Range: 18 years to No maximum
Inclusion Criteria:
* 18 years or older
* planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
* failure of at least one anti-arrhythmic drug
* others
Exclusion Criteria:
* overall good health as established by multiple criteria
Interventions
DEVICE
HeartLight
PROCEDURE
Ablation
Conditions
Atrial Fibrillation
Locations
University of Arizona Sarver HeartCenter
Tucson, Arizona 85724
United States
University of Illinois
Chicago, Illinois 60612
United States
Mount Sinai Hospital
New York, New York 10029
United States
University Of Virginia Health System
Charlottesville, Virginia 22908
United States