LifeVest Trends Validation Protocol

NCT02149290 | Completed Results FDA Device

• 1 other identifier: 90D0120
• Study Type: observational
• Target: 198
• Locations: 3 countries
• Sites: 21

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).

Conditions

Heart Failure

Keywords

Heart Failure; Six minute walk test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compliance With Completing 6MWT Through a Wearable Defibrillator.

  Up to 12-14 Weeks of WCD use

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

  Up to 12-14 Weeks of WCD use

Other Outcomes (1)

• Patient Interactions With the Wearable Defibrillator

  Three months

Study Arms (1)

Trends-equipped LifeVest 4000

Subjects using the LifeVest 4000 modified to collect Trends data

Device: Trends-equipped LifeVest 4000

Interventions

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

Trends-equipped LifeVest 4000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (21)

Orange County Heart Institute

Orange, California, 92868, United States

Location

Cardiac Arrhythmia Service

Boca Raton, Florida, 33432, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30046, United States

Location

Lexington Cardiology Consultants

Lexington, Kentucky, 40503, United States

Location

Cardiology Institute of Michigan

Flint, Michigan, 48507, United States

Location

SUNY Downstate

Brooklyn, New York, 11203, United States

Location

Oklahoma Heart Hospital

Oklahoma City, Oklahoma, 73120, United States

Location

Erlanger Clinical Research

Chattanooga, Tennessee, 37403, United States

Location

Methodist Healthcare Foundation

Memphis, Tennessee, 38104, United States

Location

VA Beach General

Virginia Beach, Virginia, 23454, United States

Location

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

CAMC

Charleston, West Virginia, 25304, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Klinische Abteilung für Kardiologie

Graz, 8036, Austria

Location

Universitats-Herzzentrum Freiburg - Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Kerckhoff-Klinik

Bad Nauheim, Germany

Location

Medizinische Klinik & Poliklinik II - Kardiologie

Bonn, 53105, Germany

Location

Klinikum Coburg

Coburg, 96450, Germany

Location

St. Vinzenz Hospital

Cologne, 50733, Germany

Location

Department für Herzinsuffizienz und Devicetherap

Hamburg, Germany

Location

Klinik für Innere Medizin III

Villingen-Schwenningen, 78052, Germany

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: VP of Medical Affairs
• Organization: ZOLL LifeVest

stevens@zoll.com

412-968-3333

Study Officials

• Steven J Szymkiewicz, MD

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 29, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 31, 2020
• Results First Posted: August 31, 2020

Record last verified: 2020-08

Locations

US (13); DE (7); AU (1)