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Detect Fluid Early From Intra-thoracic Impedance Monitoring (DEFEAT-PE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916929
First Posted: June 10, 2009
Last Update Posted: July 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Condition Intervention
Heart Failure Device: Impedance Monitoring Feature

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Detect Fluid Early From Intra-thoracic Impedance Monitoring

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • False Positive Rate [ Time Frame: 6-months ]
    False Positive Rate is the the number of departures from the device's programmed threshold that are unrelated to a heart failure event. The False Positive Rate per patient year of follow up should be less than 1.5.


Secondary Outcome Measures:
  • Sensitivity [ Time Frame: 6-months ]
    Sensitivity is defined as the ability of the algorithm to detect heart failure events. Sensitivity is calculated as the number of heart failure events detected by the algorithm (true positives) divided by the total number of heart failure events (true positives + false positives).


Enrollment: 162
Study Start Date: May 2009
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Implantable Cardioverter Defibrillator (ICD)
Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Device: Impedance Monitoring Feature
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Cardiac Resynchronization Therapy (CRT-D)
Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
Device: Impedance Monitoring Feature
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
  • Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Exclusion Criteria:

  • History of kidney disease requiring hemodialysis
  • Refractory end stage heart failure
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00916929


  Show 34 Study Locations
Sponsors and Collaborators
St. Jude Medical
Investigators
Study Chair: Edwin K Heist, MD, PhD Massachusetts General Hospital
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00916929     History of Changes
Other Study ID Numbers: 40006062/D
First Submitted: June 8, 2009
First Posted: June 10, 2009
Results First Submitted: December 18, 2012
Results First Posted: June 24, 2013
Last Update Posted: July 2, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases