Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420108
Status:
COMPLETED
Last Update Posted:
2010-08-20
First Post:
2007-01-08
Brief Title:
Optivol Diagnostic Data for Discharge in Heart Failure
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness
Status:
COMPLETED
Status Verified Date:
2010-08
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:
3DHF
Brief Summary:
The objective of this study is to evaluate whether the heart rate variability daily heart rate andor intrathoracic impedance recorded by implantable cardiac devices can be used in conjunction with other traditional clinical practice methods to determine if heart failure patients are ready for hospital discharge
Detailed Description:
Implantable cardioverter defibrillator ICD devices with or without cardiac resynchronization therapy CRT-D have the ability to continuously monitor heart rate variability daily heart rate and patient activity Changes in these measures have been associated with heart failure prognosis In addition ICD or CRT-D devices also have the ability to measure daily intrathoracic impedance Previous data have demonstrated that device-based intrathoracic impedance measurements correlate with pulmonary capillary wedge pressure and fluid retention both of which are common measures of heart failure status The objective of this study is to evaluate whether the heart rate variability daily heart rate andor intrathoracic impedance can be used in conjunction with other methods to determine if patients are ready for hospital discharge This will be the first step in potentially developing an inpatient care strategy which includes implantable device data It is hypothesized that device diagnostic data will identify an appropriate and safe time to discharge patients admitted for worsening heart failure symptoms before usual clinical indicators More specifically we hypothesize that device data will normalize at least one day prior to the clinical indicators of readiness for discharge and patients discharged prior to normalization of the device data will be at greater risk for rehospitalization
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