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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by St. Jude Medical.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00916929
First received: June 8, 2009
Last updated: April 4, 2011
Last verified: April 2011
History of Changes
  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: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary endpoint is intended to demonstrate that the number of departures from the stability zone that are unrelated to a pulmonary congestion event (False Positive) per patient-year of follow-up is less than 1.5. [ Time Frame: 6-months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sensitivity of the index to detect events will be calculated as the proportion of events with a related departure. [ Time Frame: 6-months ] [ Designated as safety issue: No ]

Enrollment: 162
Study Start Date: May 2009
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ICD Device: Impedance Monitoring Feature
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
CRT-D 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 SJM ICD or CRT-D for at least 31 days
  • Must have had an episode of ADHF within past 6 months

Exclusion Criteria:

  • History of kidney disease requiring hemodialysis
  • Refractory end stage heart failure
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916929

Locations
United States, Arizona
Arizona Arrhythmia Consultants
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Arkansas Cardiology, PA
Little Rock, Arkansas, United States, 72005
Little Rock Cardiology Clinic, PA
Little Rock, Arkansas, United States, 72211
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: Tamara Shipman, St Jude Medical
ClinicalTrials.gov Identifier: NCT00916929     History of Changes
Other Study ID Numbers: 40006062/D
Study First Received: June 8, 2009
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013