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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00916929
First received: June 8, 2009
Last updated: June 21, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00916929

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

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014