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LifeVest Trends Validation Protocol (TRENDS)

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ClinicalTrials.gov Identifier: NCT02149290
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Brief Summary:
This study will evaluate the accuracy of data on body position, daily activity, heart rate, 6-minute walk test, and a health survey collected by the wearable cardioverter defibrillator (WCD).

Condition or disease Intervention/treatment
Heart Failure Device: Trends-equipped LifeVest 4000

Detailed Description:
This is a multi-center validation study of heart failure patients wearing the LifeVest WCD modified to collect data on body position, activity, heart rate, 6-minute walk test, and a health survey in order to evaluate data accuracy and patient interactions with the device.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: LifeVest Trends Validation Protocol
Study Start Date : February 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Trends-equipped LifeVest 4000
Subjects using the LifeVest 4000 modified to collect Trends data
Device: 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; activity data collection; ability to perform a health survey; ability to guide patients through a walk test




Primary Outcome Measures :
  1. Precision of Heart Failure (HF) metrics measurements [ Time Frame: Three months ]
    Relationship of the step count and distance measure of the LifeVest walk test in heart failure patients as compared to distance measure of medically supervised 6-minute walk test. Accuracy of daily heart rate, activities, and body position in patients with heart failure as compated to patient diaries of activity and sleeping position.


Secondary Outcome Measures :
  1. Patient interactions with the Trends user interface [ Time Frame: Three months ]
    Compliance with answering questions regarding health through the WCD interface, and following instructions for the performance of a 6-minute walk test given by the wearable defibrillator.


Other Outcome Measures:
  1. Patient interactions with the wearable defibrillator [ Time Frame: Three months ]
    Compliance with WCD use during the study period, and patient-device interactions during a ventricular arrhythmia, if any should occur during the study period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with heart failure who are being cared for in an outpatient environment
Criteria

Inclusion Criteria:

  • Symptomatic heart failure (i.e., New York Heart Association (NYHA) class II or higher)
  • 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:

  • Use of an implantable cardioverter defibrillator (ICD), recent removal of an ICD, or planned use of an ICD within the next three months
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149290


Locations
United States, California
Orange County Heart Institute
Orange, California, United States, 92868
United States, Florida
Cardiac Arrhythmia Service
Boca Raton, Florida, United States, 33432
United States, Georgia
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30046
United States, Kentucky
Lexington Cardiology Consultants
Lexington, Kentucky, United States, 40503
United States, Michigan
Cardiology Institute of Michigan
Flint, Michigan, United States, 48507
United States, New York
SUNY Downstate
Brooklyn, New York, United States, 11203
United States, Oklahoma
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States, 73120
United States, Tennessee
Erlanger Clinical Research
Chattanooga, Tennessee, United States, 37403
Methodist Healthcare Foundation
Memphis, Tennessee, United States, 38104
United States, Virginia
VA Beach General
Virginia Beach, Virginia, United States, 23454
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
United States, West Virginia
CAMC
Charleston, West Virginia, United States, 25304
St. Mary's Medical Center
Huntington, West Virginia, United States, 25702
Austria
Klinische Abteilung für Kardiologie
Graz, Austria, 8036
Germany
Universitats-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Germany, 79189
Kerckhoff-Klinik
Bad Nauheim, Germany
Medizinische Klinik & Poliklinik II - Kardiologie
Bonn, Germany, 53105
Klinikum Coburg
Coburg, Germany, 96450
Department für Herzinsuffizienz und Devicetherap
Hamburg, Germany
St. Vinzenz Hospital
Köln, Germany, 50733
Klinik für Innere Medizin III
Villingen-Schwenningen, Germany, 78052
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Steven J Szymkiewicz, MD Zoll Medical Corporation

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT02149290     History of Changes
Other Study ID Numbers: 90D0120
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018

Keywords provided by Zoll Medical Corporation:
Heart Failure
Six minute walk test

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases