Optivol Diagnostic Data for Discharge in Heart Failure

Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00420108

Acronym

3DHF

Enrollment

Registered

2007-01-09

Start date

2006-12-31

Completion date

2010-02-28

Last updated

2010-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacemaker, Artificial, Heart Failure, Congestive

Keywords

Heart Failure, Congestive, Cardiac Pacemaker, Artificial, Ventricular Pressure

Brief summary

The objective of this study is to evaluate whether the heart rate variability, daily heart rate, and/or 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, and/or 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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol capability for \>30 days. * Anticipated hospitalization stay \>48 hours * Hospitalized patients experiencing worsening heart failure with symptoms of lung/pulmonary congestion.

Exclusion criteria

* Anemia - admission hemoglobin \<8.0 g/dL * Patients residing in convalescence center prior to admission or known to be discharged to a convalescence center or hospice, where discharge could be based on bed availability

Countries

United States

Outcome results