CardioFocus HeartLight Post-Approval Study
Recruiting · NCT03168659 · Interventional (participants receive a specific treatment) · Lead sponsor: CardioFocus
View the official record on ClinicalTrials.gov →Interventions studied
AblationHeartLight
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
4 locations listed across 4 US states.
- 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