Overview
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
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