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CardioFocus HeartLight Post-Approval Study
Sponsor: CardioFocus
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.
Official title: Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2017-06-16
Completion Date
2028-10
Last Updated
2024-08-20
Healthy Volunteers
No
Conditions
Interventions
HeartLight
HeartLight Endoscopic Ablation System
Ablation
Pulmonary vein isolation ablation
Locations (4)
University of Arizona Sarver HeartCenter
Tucson, Arizona, United States
University of Illinois
Chicago, Illinois, United States
Mount Sinai Hospital
New York, New York, United States
University Of Virginia Health System
Charlottesville, Virginia, United States