CardioFocus HeartLight Post-Approval Study

ConditionAtrial Fibrillation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCardioFocus

About this trial

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.

Eligibility criteria

Qualifiers

18 years or older

planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation

failure of at least one anti-arrhythmic drug

others

Disqualifiers

overall good health as established by multiple criteria

Trial design

Treatments tested in this trial

HeartLight
Ablation

Treatment groups

250 Participants

are divided into 1 treatment group

Sponsors and collaborators

CardioFocus

Lead sponsor

Source ClinicalTrials.gov