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Sponsors and Collaborators: |
Thomas Jefferson University Medtronic |
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Information provided by: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT00420108 |
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.
Condition |
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Heart Failure, Congestive Cardiac Pacemaker, Artificial |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness |
No biospecimens to be retained
Estimated Enrollment: | 40 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2008 |
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.
Inclusion Criteria:
Exclusion Criteria:
Contact: Alicia Ervin, BSN RN | 215 955 2050 | alicia.ervin@jefferson.edu |
United States, Missouri | |
Heartland Health | Recruiting |
St. Joseph, Missouri, United States, 64506 | |
Contact: Faye Eckert, RN 816-271-6718 | |
Principal Investigator: Martin Sulllivan, MD | |
United States, New Jersey | |
Cardiovascular Associates of Delaware Valley | Recruiting |
Elmer, New Jersey, United States, 083618 | |
Contact: Michele Cale-Ferry, RN 856-582-2000 | |
Principal Investigator: George Mark, MD | |
United States, Pennsylvania | |
Thomas Jefferson University | Recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Principal Investigator: David J. Whellan, MD MHS | |
Sub-Investigator: Paul J. Mather, MD | |
Sub-Investigator: Sharon Rubin, MD | |
Temple University | Recruiting |
Philadelphia, Pennsylvania, United States, 19140 | |
Contact: Jenny Wong 215-707-5340 wongjk@tuhs.temple.edu | |
Principal Investigator: James Fitzpatrick, MD | |
Main Line Health Lankenau Hospital | Recruiting |
Wynnewood, Pennsylvania, United States, 19096 | |
Contact: Lisa Thome, RN 610-645-8570 | |
Principal Investigator: Christopher Droogan, DO |
Principal Investigator: | David J Whellan, MD MHS | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University ( Office of Research Administration ) |
Study ID Numbers: | 06U.232 |
Study First Received: | January 8, 2007 |
Last Updated: | January 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00420108 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart Failure, Congestive Cardiac Pacemaker, Artificial Ventricular Pressure |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |