Heart Failure, Congestive Clinical Trial
— 3DHFOfficial title:
Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness
Verified date | August 2010 |
Source | Thomas Jefferson University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Cardiovascular Associates of Delaware Valley | Elmer | New Jersey |
United States | Temple University | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Heartland Health | St. Joseph | Missouri |
United States | Main Line Health Lankenau Hospital | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Medtronic |
United States,
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