Ignite Creation Date:
2024-05-05 @ 10:12 PM
Last Modification Date:
2024-10-26 @ 10:15 AM
Study NCT ID:
NCT01057394
Status:
TERMINATED
Last Update Posted:
2016-08-01
First Post:
2010-01-26
Brief Title:
Post-Market Randomized Trial Endoscopically- Guided Ablation vs Radiofrequency Ablation
Sponsor:
CardioFocus
Organization:
CardioFocus
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:
None
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?:
None