Trials / Terminated
TerminatedNCT01057394
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
Post-Market Randomized Controlled Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation GuideD by Electroanatomical Mapping to Achieve Permanent Pulmonary Vein Isolation (En-GARDE)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- CardioFocus · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To compare the safety and chronic Pulmonary Vein isolation of 2 ablation types. 1. visually guided ablation (VGA) using the EAS-AC and 2. radiofrequency ablation
Detailed description
The goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (RF) ablation. The study was terminated early by the Sponsor for business reasons before any participants were randomized or treated with RF ablation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Endoscopically guided PVI Ablation | Endoscopically Guided Ablation using the EAS-AC |
| DEVICE | RF PVI Ablation | Radiofrequency ablation |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2010-01-27
- Last updated
- 2016-08-01
- Results posted
- 2016-08-01
Locations
2 sites across 2 countries: Czechia, Italy
Source: ClinicalTrials.gov record NCT01057394. Inclusion in this directory is not an endorsement.