Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412607
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2006-12-14
Brief Title:
Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia
Sponsor:
Biosense Webster Inc
Organization:
Biosense Webster Inc
Study Overview
Official Title:
NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VT-CoA
Brief Summary:
The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia
Detailed Description:
This study is a prospective non-randomized single-arm multi-center condition of approval evaluation The device is currently FDA approved for commercial distribution Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects
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