Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510198
Status:
TERMINATED
Last Update Posted:
2019-04-10
First Post:
2007-07-31
Brief Title:
Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
PRECEDE-HF -Prospective Randomized Evaluation of Cardiac Compass With OptiVol in the Early Detection of Decompensation Events for Heart Failure
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study enrollment significantly below protocol expectation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECEDE-HF
Brief Summary:
The purpose of the PRECEDE-HF study is to collect data to compare patients whose heart failure is managed using Cardiac Compass with OptiVol which is a tool in the device that records information about the heart that doctors can use to help treat their heart disease combined with standard treatment methods Access Group to patients whose heart failure is managed by standard treatment methods only Control Group This comparison will show if the additional monitoring provided by Cardiac Compass with OptiVol delays the time patients are first admitted to hospital for heart failure or delays the time to death
Detailed Description:
PRECEDE-HF was a prospective multi-center randomized investigational device exemption IDE clinical study The purpose of this study was to collect data required to determine whether the use of Cardiac Compass including OptiVol Fluid Status Monitoring with standard clinical assessment Access Arm will result in a longer time to first heart failure hospitalization or death compared to standard clinical assessment alone Control Arm and to support the approval of the following device features
OptiVol Alert audible and home monitor alerts for use in Medtronic devices
SentryCheck Monitor
OptiVol Alert Suspend OptiVol enhancement
OptiVol Reference Impedance Adjustment OptiVol enhancement
OptiVol Alert audible and home monitor alerts for use in Medtronic devices
SentryCheck Monitor
OptiVol Alert Suspend OptiVol enhancement
OptiVol Reference Impedance Adjustment OptiVol enhancement
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