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Optivol Diagnostic Data for Discharge in Heart Failure (3DHF)
This study is currently recruiting participants.
Verified by Thomas Jefferson University, January 2009
First Received: January 8, 2007   Last Updated: January 22, 2009   History of Changes
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

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

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Biospecimen Retention:   None Retained

Biospecimen Description:

No biospecimens to be retained


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
Sampling Method:   Probability Sample
Study Population

The study population is hospitalized patients who have an implanted Medtronic device with Optivol capability.

Criteria

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
  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, 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            
Sponsors and Collaborators
Thomas Jefferson University
Medtronic
Investigators
Principal Investigator: David J Whellan, MD MHS Thomas Jefferson University
  More Information

No publications provided

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

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:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 09, 2009