Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01057394
Status:
TERMINATED
Last Update Posted:
2016-08-01
First Post:
2010-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation
Sponsor:
CardioFocus
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor stopped study for business reasons; not for clinical or clinical outcomes reasons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
En-GARDE
Brief 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
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: