Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480077
Status:
TERMINATED
Last Update Posted:
2019-02-19
First Post:
2007-05-29
Brief Title:
Diagnostic Outcome Trial in Heart Failure DOT-HF Trial
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
Diagnostic Outcome Trial in Heart Failure
Status:
TERMINATED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment rates
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOT-HF
Brief Summary:
The DOT-HF trial is an international prospective multi-center randomized controlled trial
Detailed Description:
The study was designed with a Control Arm in order to adequately study the effect of early intervention triggered by the OptiVol Alert andor SentryCheck MonitorPatientLook Indicator and evaluation using OptiVol Fluid Status Monitoring with Cardiac Compass OptiVol Fluid Status Monitoring with Cardiac Compass features are available in the per Clinical Investigational Plan specified Medtronic products CRT CRT-D and ICD devices
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