Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318357
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2006-04-25
Brief Title:
CARE-HF Long Term Follow-up
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
CARE-HF LTFU CArdiac REsynchronization in Heart Failure Long-term Follow-up
Status:
COMPLETED
Status Verified Date:
2019-04
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 CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization CR therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up Investigators are free to choose whatever available treatment they believe is in the patients best interest
Detailed Description:
The CARE-HF study enrolled 813 patients from 82 centers in 12 European countries Austria Belgium Denmark Finland France Germany Italy Netherlands Spain Sweden Switzerland and UK All patients that were reported to be alive in May 2005 will be asked to participate
In the CARE-HF LTFU program patients from the CARE-HF trial were asked to be enrolled for an additional 4 year follow-up Investigators were free to choose whatever available treatment they believe is in the patients best interest however the outcome of the CARE-HF trial suggested that all patients should receive CRT therapy on top of Optimal Medical Treatment
In the CARE-HF LTFU program patients from the CARE-HF trial were asked to be enrolled for an additional 4 year follow-up Investigators were free to choose whatever available treatment they believe is in the patients best interest however the outcome of the CARE-HF trial suggested that all patients should receive CRT therapy on top of Optimal Medical Treatment
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