Study Results
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View full resultsBasic Information
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COMPLETED
198 participants
OBSERVATIONAL
2014-02-28
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Trends-equipped LifeVest 4000
Subjects using the LifeVest 4000 modified to collect Trends data
Trends-equipped LifeVest 4000
LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
Interventions
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Trends-equipped LifeVest 4000
LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
Eligibility Criteria
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Inclusion Criteria
* Evidence of a prior Myocardial Infarction (MI) or dilated cardiomyopathy
* Ejection fraction of 35% or less at the start of WCD use
* Anticipated to need a WCD for three months or more
* At least 18 years of age (over the legal age of providing consent)
Exclusion Criteria
* Need for an assistive device for ambulation (wheelchair, walker, or cane)
* Use of a unipolar pacemaker
* Physical or mental conditions that prevent interaction with or wearing of the device
* Advanced directive prohibiting resuscitation
* Pregnancy
18 Years
ALL
No
Sponsors
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Zoll Medical Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Steven J Szymkiewicz, MD
Role: STUDY_DIRECTOR
Zoll Medical Corporation
Locations
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Orange County Heart Institute
Orange, California, United States
Cardiac Arrhythmia Service
Boca Raton, Florida, United States
Gwinnett Medical Center
Lawrenceville, Georgia, United States
Lexington Cardiology Consultants
Lexington, Kentucky, United States
Cardiology Institute of Michigan
Flint, Michigan, United States
SUNY Downstate
Brooklyn, New York, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Erlanger Clinical Research
Chattanooga, Tennessee, United States
Methodist Healthcare Foundation
Memphis, Tennessee, United States
VA Beach General
Virginia Beach, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
CAMC
Charleston, West Virginia, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
Klinische Abteilung für Kardiologie
Graz, , Austria
Universitats-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, , Germany
Kerckhoff-Klinik
Bad Nauheim, , Germany
Medizinische Klinik & Poliklinik II - Kardiologie
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
St. Vinzenz Hospital
Cologne, , Germany
Department für Herzinsuffizienz und Devicetherap
Hamburg, , Germany
Klinik für Innere Medizin III
Villingen-Schwenningen, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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90D0120
Identifier Type: -
Identifier Source: org_study_id
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