Trials / Recruiting
RecruitingNCT03168659
CardioFocus HeartLight Post-Approval Study
Post-Approval Study of the HeartLight Endoscopic Ablation System for the Treatment of Atrial Fibrillation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- CardioFocus · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HeartLight | HeartLight Endoscopic Ablation System |
| PROCEDURE | Ablation | Pulmonary vein isolation ablation |
Timeline
- Start date
- 2017-06-16
- Primary completion
- 2026-10-01
- Completion
- 2028-10-01
- First posted
- 2017-05-30
- Last updated
- 2024-08-20
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03168659. Inclusion in this directory is not an endorsement.