Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
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.
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
- DeviceHeartLight
HeartLight Endoscopic Ablation System
- ProcedureAblation
Pulmonary vein isolation ablation
Locations (4)
- University of Arizona Sarver HeartCenterTucson, Arizona
- University of IllinoisChicago, Illinois
- Mount Sinai HospitalNew York, New York
- University Of Virginia Health SystemCharlottesville, Virginia