Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:06 PM
Study NCT ID:
NCT00980057
Status:
COMPLETED
Last Update Posted:
2018-10-16
First Post:
2009-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Adaptive Cardiac Resynchronization Therapy Study
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Study Overview
Official Title:
Adaptive Cardiac Resynchronization Therapy Study
Status:
COMPLETED
Status Verified Date:
2018-09
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:
aCRT
Brief Summary:
The purpose of this study is to demonstrate the AdaptivCRT algorithm is at least as good as manual echo based optimization in regard to patient outcomes and cardiac performance
Detailed Description:
The trial has 3 primary end points:
* to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
* to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
* to demonstrate that aCRT does not result in inappropriate AV or VV delay settings
* to demonstrate that over 6-month follow-up, the proportion of the patients improved in the aCRT arm is at least as high as in the Echo arm
* to demonstrate that cardiac function is similar when using aCRT versus echo-optimized settings
* to demonstrate that aCRT does not result in inappropriate AV or VV delay settings
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?: