CardioFocus HeartLight Post-Approval Study
Purpose
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.
Condition
- Atrial Fibrillation
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Treatment |
Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System |
|
Recruiting Locations
University of Arizona Sarver HeartCenter
Tucson, Arizona 85724
Tucson, Arizona 85724
University of Illinois
Chicago, Illinois 60612
Chicago, Illinois 60612
Mount Sinai Hospital
New York, New York 10029
New York, New York 10029
University Of Virginia Health System
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
More Details
- Status
- Recruiting
- Sponsor
- CardioFocus
Detailed 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.