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CardioFocus HeartLight Post-Approval Study
Recruiting
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- HeartLight (device)
- Ablation (procedure)
Sponsor: CardioFocus · Participants: 250 · Started: Jun 16, 2017
Contact the study team
- Study Director · Phone: 508-658-7253
Official record on ClinicalTrials.gov — NCT03168659
Locations in the U.S.
| Arizona | University of Arizona Sarver HeartCenter, Tucson |
| Illinois | University of Illinois, Chicago |
| New York | Mount Sinai Hospital, New York |
| Virginia | University Of Virginia Health System, Charlottesville |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.