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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Impedance Monitoring Feature
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Arrhythmia Research Center
  • Arkansas Cardiology, PA
  • Little Rock Cardiology Clinic, PA
  • Glendale Memorial Hospital and MC
  • Cardiac Rhythm Specialists, Inc
  • Colorado Cardiac Alliance, LLC
  • Shands Jacksonville
  • Watson Clinic Center
  • Orlando Heart Center
  • Tallahassee Research Institute
  • Iowa Heart Center
  • Massachusetts General Hospital
  • Cardiology Consultants of East Michigan
  • Thoracic Cardiovascular HC Found. (Sparrow Research)
  • Hattiesburg Clinic
  • North Mississippi Medical Center
  • Deborah Heart and Lung Center
  • Associated Cardiovascular Consultants
  • New York Presbyterian Hospital / Cornell University
  • Mid Carolina Cardiology
  • The Cleveland Clinic Foundation
  • Ohio State University
  • Mercy Hospital Fairfield
  • Saint Vincent Consultants in Cardiovascular Diseases
  • Hospital of the University of PA
  • Thomas Jefferson University Hospital
  • York Hospital
  • Medical University of South Carolina
  • Methodist University Hospital
  • St Thomas Hospital
  • South Texas Cardiovascular Consultants
  • Sentara Norfolk General Hospital
  • The Hope Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Implantable Cardioverter Defibrillator (ICD)

Cardiac Resynchronization Therapy (CRT-D)

Arm Description

Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).

Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
June 8, 2009
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00916929
Brief Title
Detect Fluid Early From Intra-thoracic Impedance Monitoring
Acronym
DEFEAT-PE
Official Title
Detect Fluid Early From Intra-thoracic Impedance Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Non-Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Implantable Cardioverter Defibrillator (ICD)
Arm Type
Other
Arm Description
Impedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Arm Title
Cardiac Resynchronization Therapy (CRT-D)
Arm Type
Other
Arm Description
Impedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
Intervention Type
Device
Intervention Name(s)
Impedance Monitoring Feature
Intervention Description
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Primary Outcome Measure Information:
Title
False Positive Rate
Description
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.
Time Frame
6-months
Secondary Outcome Measure Information:
Title
Sensitivity
Description
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).
Time Frame
6-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edwin K Heist, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Arizona Arrhythmia Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arkansas Cardiology, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72005
Country
United States
Facility Name
Little Rock Cardiology Clinic, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Glendale Memorial Hospital and MC
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Cardiac Rhythm Specialists, Inc
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Colorado Cardiac Alliance, LLC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Shands Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Watson Clinic Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Orlando Heart Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Iowa Heart Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Cardiology Consultants of East Michigan
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Thoracic Cardiovascular HC Found. (Sparrow Research)
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
North Mississippi Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Deborah Heart and Lung Center
City
Browns Mills
State/Province
New Jersey
ZIP/Postal Code
08015
Country
United States
Facility Name
Associated Cardiovascular Consultants
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
New York Presbyterian Hospital / Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mid Carolina Cardiology
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Mercy Hospital Fairfield
City
Fairfield
State/Province
Ohio
ZIP/Postal Code
45014
Country
United States
Facility Name
Saint Vincent Consultants in Cardiovascular Diseases
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16502
Country
United States
Facility Name
Hospital of the University of PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
St Thomas Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
South Texas Cardiovascular Consultants
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
The Hope Heart Institute
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

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Detect Fluid Early From Intra-thoracic Impedance Monitoring

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