Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00180336
Status:
COMPLETED
Last Update Posted:
2007-06-25
First Post:
2005-09-12
Brief Title:
Safety and Efficacy Study of RENEWAL 4 AVT
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
CONTAK RENEWAL 4 AVT Field Following
Status:
COMPLETED
Status Verified Date:
2007-06
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:
None
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of the CONTAK RENEWAL 4 AVT device
Detailed Description:
This is a prospective two-arm non-randomized multi-center European field following designed to demonstrate the safety and effectiveness of the CONTAK RENEWAL 4 AVT device in humans
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