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

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.
 
ClinicalTrials.gov Identifier: NCT00916929
Recruitment Status : Completed
First Posted : June 10, 2009
Results First Posted : June 24, 2013
Last Update Posted : February 19, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Impedance Monitoring Feature Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
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
Study Start Date : May 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Edwin K Heist, MD, PhD Massachusetts General Hospital
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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT00916929    
Other Study ID Numbers: 40006062/D
First Posted: June 10, 2009    Key Record Dates
Results First Posted: June 24, 2013
Last Update Posted: February 19, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases