Optivol Diagnostic Data for Discharge in Heart Failure

Completed

Conditions studied: Heart Failure, Congestive, Cardiac Pacemaker, Artificial

In brief

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.

Key facts

Study ID

NCT00420108

Run by

Thomas Jefferson University

People needed

23

Starts

2006-12-01

Expected to finish

2010-02-01

Last updated by the study team

2010-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Heartland Health — Saint Joseph, Missouri, United States
• Cardiovascular Associates of Delaware Valley — Elmer, New Jersey, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Temple University — Philadelphia, Pennsylvania, United States
• Main Line Health Lankenau Hospital — Wynnewood, Pennsylvania, United States

Full record on ClinicalTrials.gov

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