Trials / Completed
CompletedNCT01456000
HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)
Pivotal Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) or HEARTLIGHT for the Treatment of Symptomatic Atrial Fibrillation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 405 (actual)
- Sponsor
- CardioFocus · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the safety and effectiveness of the CardioFocus Endoscopic Ablation System with Adaptive Contact (HeartLight) in the treatment of atrial fibrillation by creating electrical isolation of the pulmonary veins.
Detailed description
A randomized, controlled trial designed to demonstrate the safety and effectiveness of the experimental device to deliver pulmonary vein isolation as a treatment for symptomatic atrial fibrillation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EAS-AC (HeartLight) | Pulmonary vien isolation |
| PROCEDURE | Control Arm Ablation | Treatment with standard ablation. |
Timeline
- Start date
- 2012-01-01
- Primary completion
- 2014-12-01
- Completion
- 2016-01-01
- First posted
- 2011-10-20
- Last updated
- 2016-09-08
- Results posted
- 2016-09-08
Locations
21 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01456000. Inclusion in this directory is not an endorsement.