Optivol Diagnostic Data for Discharge in Heart Failure (3DHF)
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ClinicalTrials.gov Identifier: NCT00420108 |
Recruitment Status
:
Completed
First Posted
: January 9, 2007
Last Update Posted
: August 20, 2010
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Condition or disease |
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Heart Failure, Congestive Cardiac Pacemaker, Artificial |
Study Type : | Observational |
Actual Enrollment : | 23 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |


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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00420108
United States, Missouri | |
Heartland Health | |
St. Joseph, Missouri, United States, 64506 | |
United States, New Jersey | |
Cardiovascular Associates of Delaware Valley | |
Elmer, New Jersey, United States, 083618 | |
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 | |
Temple University | |
Philadelphia, Pennsylvania, United States, 19140 | |
Main Line Health Lankenau Hospital | |
Wynnewood, Pennsylvania, United States, 19096 |
Principal Investigator: | David J Whellan, MD MHS | Thomas Jefferson University |
Responsible Party: | Office of Research Administration, Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00420108 History of Changes |
Other Study ID Numbers: |
06U.232 |
First Posted: | January 9, 2007 Key Record Dates |
Last Update Posted: | August 20, 2010 |
Last Verified: | August 2010 |
Keywords provided by Thomas Jefferson University:
Heart Failure, Congestive Cardiac Pacemaker, Artificial Ventricular Pressure |
Additional relevant MeSH terms:
Heart Failure Heart Diseases Cardiovascular Diseases |