Status:
COMPLETED
Optivol Diagnostic Data for Discharge in Heart Failure
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
Medtronic
Conditions:
Heart Failure, Congestive
Cardiac Pacemaker, Artificial
Eligibility:
All Genders
18+ years
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 ...
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 pa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00420108
Start Date
December 1 2006
End Date
February 1 2010
Last Update
August 20 2010
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Heartland Health
Saint Joseph, Missouri, United States, 64506
2
Cardiovascular Associates of Delaware Valley
Elmer, New Jersey, United States, 083618
3
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
4
Temple University
Philadelphia, Pennsylvania, United States, 19140