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Completed

NCT Number: NCT02149290

LifeVest Trends Validation Protocol

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinische Abteilung für Kardiologie, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trends-equipped LifeVest 4000

Device

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

Primary outcomes

  1. Distance Traveled in Six Minute Walk Test

    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 activities, and body position in patients with heart failure as compared to patient diaries of activity and sleeping position.

Secondary outcomes

  1. Compliance With Completing 6MWT Through a Wearable Defibrillator.

    Time frame: Up to 12-14 Weeks of WCD use

    Observe Compliance with completing weekly 6MWT

  2. Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.

    Time frame: Up to 12-14 Weeks of WCD use

    Observe compliance with answering daily health survey.

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

Zoll Medical Corporation

Industry

Registry information

Acronym: TRENDS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 29, 2014
Registry last updated
Aug 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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