Clinical trial NCT02149290: LifeVest Trends Validation Protocol
Official title: LifeVest Trends Validation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Six minute walk test
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure who are being cared for in an outpatient environment

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).

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.

Eligibility 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

Primary outcomes:
measure: Distance Traveled in Six Minute Walk Test
timeFrame: Three months
Secondary outcomes:
measure: Compliance With Completing 6MWT Through a Wearable Defibrillator.
timeFrame: Up to 12-14 Weeks of WCD use
measure: Observe Compliance With Answering Questions Regarding Health Through a Wearable Defibrillator.
timeFrame: Up to 12-14 Weeks of WCD use
Other outcomes:
measure: Patient Interactions With the Wearable Defibrillator
timeFrame: Three months
Locations:
city: Orange
country: United States
facility: Orange County Heart Institute
state: California
city: Boca Raton
country: United States
facility: Cardiac Arrhythmia Service
state: Florida
city: Lawrenceville
country: United States
facility: Gwinnett Medical Center
state: Georgia
city: Lexington
country: United States
facility: Lexington Cardiology Consultants
state: Kentucky
city: Flint
country: United States
facility: Cardiology Institute of Michigan
state: Michigan
city: Brooklyn
country: United States
facility: SUNY Downstate
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Chattanooga
country: United States
facility: Erlanger Clinical Research
state: Tennessee
city: Memphis
country: United States
facility: Methodist Healthcare Foundation
state: Tennessee
city: Virginia Beach
country: United States
facility: VA Beach General
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Charleston
country: United States
facility: CAMC
state: West Virginia
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Graz
country: Austria
facility: Klinische Abteilung für Kardiologie
city: Bad Krozingen
country: Germany
facility: Universitats-Herzzentrum Freiburg - Bad Krozingen
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik
city: Bonn
country: Germany
facility: Medizinische Klinik & Poliklinik II - Kardiologie
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Hamburg
country: Germany
facility: Department für Herzinsuffizienz und Devicetherap
city: Köln
country: Germany
facility: St. Vinzenz Hospital
city: Villingen-Schwenningen
country: Germany
facility: Klinik für Innere Medizin III
Study officials:
affiliation: Zoll Medical Corporation
name: Steven J Szymkiewicz, MD
role: STUDY_DIRECTOR
References: