LifeVest Trends Validation Protocol (TRENDS)

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: 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
• Enrollment (Actual): 198

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients with heart failure who are being cared for in an outpatient environment

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Traveled in Six Minute Walk Test	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 activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance With Completing 6MWT Through a Wearable Defibrillator.	Observe Compliance with completing weekly 6MWT	Up to 12-14 Weeks of WCD use
Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.	Observe compliance with answering daily health survey.	Up to 12-14 Weeks of WCD use

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Interactions With the Wearable Defibrillator	Compliance with WCD use during the study period, and patient-device interactions during a ventricular arrhythmia, if any should occur during the study period.	Three months

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (ESTIMATE): May 29, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Heart Failure; Six minute walk test
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 90D0120

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes