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Optivol Diagnostic Data for Discharge in Heart Failure
This study is currently recruiting participants.
Verified by Thomas Jefferson University, January 2007
Sponsors and Collaborators: Thomas Jefferson University
Medtronic
Information provided by: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00420108
  Purpose

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
Heart Failure, Congestive
Cardiac Pacemaker, Artificial

MedlinePlus related topics: Heart Failure Pacemakers and Implantable Defibrillators
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: Comparing ICD Device Diagnostics to Hospitalized Heart Failure Patient Symptoms and Physician Opinion on Discharge Readiness

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment: 40
Study Start Date: December 2006
Estimated Study Completion Date: December 2008
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 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients implanted with a Medtronic InSync Sentry or subsequent FDA-approved Medtronic device with the OptiVol feature for > 30 days.
  • Anticipated hospitalization stay ≥ 48 hours
  • Patients hospitalized with primary diagnosis of worsening heart failure with symptoms of lung/pulmonary congestion.

Exclusion Criteria:

  • Renal dysfunction:

    • admission serum creatinine ≥ 3.0 mg/dL
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00420108

Contacts
Contact: Alicia Ervin, BSN RN 215 955 2050 alicia.ervin@jefferson.edu

Locations
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            
Lehigh Valley Health System Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Joanne Smith, RN     610-402-5015     Joanne.Smith@lvh.com    
Principal Investigator: Michael Rossi, MD            
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Jenny Wong     215-707-5340     wongjk@tuhs.temple.edu    
Principal Investigator: James Fitzpatrick, MD            
Sponsors and Collaborators
Thomas Jefferson University
Medtronic
Investigators
Principal Investigator: David J Whellan, MD MHS Thomas Jefferson University
  More Information

Study ID Numbers: 06U.232
Study First Received: January 8, 2007
Last Updated: January 8, 2007
ClinicalTrials.gov Identifier: NCT00420108  
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Heart Failure, Congestive
Cardiac Pacemaker, Artificial
Ventricular Pressure

Study placed in the following topic categories:
Heart Failure
Heart Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009