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

This study has been completed.
Information provided by (Responsible Party):
St. Jude Medical Identifier:
First received: June 8, 2009
Last updated: June 21, 2013
Last verified: June 2013
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: Double Blind (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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00916929

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

Responsible Party: St. Jude Medical Identifier: NCT00916929     History of Changes
Other Study ID Numbers: 40006062/D
Study First Received: June 8, 2009
Results First Received: December 18, 2012
Last Updated: June 21, 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017