Detect Fluid Early From Intra-thoracic Impedance Monitoring
DEFEAT-PE
1 other identifier
interventional
162
1 country
34
Brief Summary
To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started May 2009
Typical duration for not_applicable heart-failure
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 8, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
June 24, 2013
CompletedFebruary 19, 2019
February 1, 2019
1.8 years
June 8, 2009
December 18, 2012
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Sensitivity
6-months
Study Arms (2)
Implantable Cardioverter Defibrillator (ICD)
OTHERImpedance Monitoring Feature in an Implantable Cardioverter Defibrillator (ICD).
Cardiac Resynchronization Therapy (CRT-D)
OTHERImpedance Monitoring Feature in a Cardiac Resynchronization Therapy (CRT-D) device.
Interventions
Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of kidney disease requiring hemodialysis
- Refractory end stage heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Arizona Arrhythmia Research Center
Phoenix, Arizona, 85016, United States
Arkansas Cardiology, PA
Little Rock, Arkansas, 72005, United States
Little Rock Cardiology Clinic, PA
Little Rock, Arkansas, 72211, United States
Glendale Memorial Hospital and MC
Glendale, California, 91204, United States
Cardiac Rhythm Specialists, Inc
Northridge, California, 91325, United States
Colorado Cardiac Alliance, LLC
Colorado Springs, Colorado, 80907, United States
Shands Jacksonville
Jacksonville, Florida, 32209, United States
Watson Clinic Center
Lakeland, Florida, 33805, United States
Orlando Heart Center
Orlando, Florida, 32806, United States
Tallahassee Research Institute
Tallahassee, Florida, 32308, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Cardiology Consultants of East Michigan
Flint, Michigan, 48532, United States
Thoracic Cardiovascular HC Found. (Sparrow Research)
Lansing, Michigan, 48910, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801, United States
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015, United States
Associated Cardiovascular Consultants
Cherry Hill, New Jersey, 08034, United States
New York Presbyterian Hospital / Cornell University
New York, New York, 10021, United States
Mid Carolina Cardiology
Charlotte, North Carolina, 28204, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Mercy Hospital Fairfield
Fairfield, Ohio, 45014, United States
Saint Vincent Consultants in Cardiovascular Diseases
Erie, Pennsylvania, 16502, United States
Hospital of the University of PA
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
York Hospital
York, Pennsylvania, 17403, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Methodist University Hospital
Memphis, Tennessee, 38104, United States
St Thomas Hospital
Nashville, Tennessee, 37205, United States
South Texas Cardiovascular Consultants
San Antonio, Texas, 78201, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
The Hope Heart Institute
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
There were no limitations of the trial.
Results Point of Contact
- Title
- Tamara Shipman
- Organization
- St Jude Medical
Study Officials
- STUDY CHAIR
Edwin K Heist, MD, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2009
First Posted
June 10, 2009
Study Start
May 1, 2009
Primary Completion
February 1, 2011
Study Completion
March 1, 2012
Last Updated
February 19, 2019
Results First Posted
June 24, 2013
Record last verified: 2019-02