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

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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Impedance Monitoring Feature

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Arizona Arrhythmia Research Center
  • Arkansas
    • Little Rock, Arkansas, United States, 72005
      • Arkansas Cardiology, PA
    • Little Rock, Arkansas, United States, 72211
      • Little Rock Cardiology Clinic, PA
  • California
    • Glendale, California, United States, 91204
      • Glendale Memorial Hospital and MC
    • Northridge, California, United States, 91325
      • Cardiac Rhythm Specialists, Inc
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Cardiac Alliance, LLC
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Shands Jacksonville
    • Lakeland, Florida, United States, 33805
      • Watson Clinic Center
    • Orlando, Florida, United States, 32806
      • Orlando Heart Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Flint, Michigan, United States, 48532
      • Cardiology Consultants of East Michigan
    • Lansing, Michigan, United States, 48910
      • Thoracic Cardiovascular HC Found. (Sparrow Research)
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Medical Center
  • New Jersey
    • Browns Mills, New Jersey, United States, 08015
      • Deborah Heart and Lung Center
    • Cherry Hill, New Jersey, United States, 08034
      • Associated Cardiovascular Consultants
  • New York
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital / Cornell University
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Mid Carolina Cardiology
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Fairfield, Ohio, United States, 45014
      • Mercy Hospital Fairfield
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16502
      • Saint Vincent Consultants in Cardiovascular Diseases
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of PA
    • York, Pennsylvania, United States, 17403
      • York Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital
    • Nashville, Tennessee, United States, 37205
      • St Thomas Hospital
  • Texas
    • San Antonio, Texas, United States, 78201
      • South Texas Cardiovascular Consultants
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Bellevue, Washington, United States, 98004
      • The Hope Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
False Positive Rate	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.	6-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	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).	6-months

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Edwin K Heist, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: June 8, 2009
• First Submitted That Met QC Criteria: June 8, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 40006062/D