Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older
• planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation
• failure of at least one anti-arrhythmic drug
• others
Locations
United States
Arizona
University of Arizona Sarver HeartCenter
RECRUITING
Tucson
Illinois
University of Illinois
RECRUITING
Chicago
New York
Mount Sinai Hospital
RECRUITING
New York
Virginia
University Of Virginia Health System
RECRUITING
Charlottesville
Contact Information
Primary
Study Director
lhausmann@cardiofocus.com
508-658-7253
Time Frame
Start Date: 2017-06-16
Estimated Completion Date: 2028-10
Participants
Target number of participants: 250
Treatments
Other: Treatment
Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System
Related Therapeutic Areas
Sponsors
Leads: CardioFocus