Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158951
Status:
COMPLETED
Last Update Posted:
2007-06-25
First Post:
2005-09-08
Brief Title:
Device Evaluation of Contak Renewal 2and Easytrak 2 - DECREASE-HF
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Device Evaluation of CONTAKR RENEWAL 244HE and EASYTRAKR 2 Assessment of Safety and Effectiveness in Heart Failure DECREASE-HF
Status:
COMPLETED
Status Verified Date:
2007-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the CONTAK RENEWAL 244HE cardiac resynchronization therapy defibrillator CRT-D family and EASYTRAK 2 lead in delivering LV-CRT or BiV-CRT with an LV Offset for patients with heart failure and an indication for an ICD
Detailed Description:
This clinical investigation is a prospective multi-center randomized double-blind study design enrolling 360 patients at 57 centers to demonstrate the safety and effectiveness of the therapy the CONTAK RENEWAL 244HE devices and the EASYTRAK 2 lead
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