LifeVest Trends Validation Protocol

Heart Failure Clinical Trial

— TRENDS  

Official title:

LifeVest Trends Validation Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149290
• Other study ID #: 90D0120
• Status: Completed
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: August 2020
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Austria	Klinische Abteilung für Kardiologie	Graz
Germany	Universitats-Herzzentrum Freiburg - Bad Krozingen	Bad Krozingen
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Medizinische Klinik & Poliklinik II - Kardiologie	Bonn
Germany	Klinikum Coburg	Coburg
Germany	Department für Herzinsuffizienz und Devicetherap	Hamburg
Germany	St. Vinzenz Hospital	Köln
Germany	Klinik für Innere Medizin III	Villingen-Schwenningen
United States	Cardiac Arrhythmia Service	Boca Raton	Florida
United States	SUNY Downstate	Brooklyn	New York
United States	CAMC	Charleston	West Virginia
United States	Erlanger Clinical Research	Chattanooga	Tennessee
United States	Cardiology Institute of Michigan	Flint	Michigan
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Lexington Cardiology Consultants	Lexington	Kentucky
United States	Methodist Healthcare Foundation	Memphis	Tennessee
United States	Oklahoma Heart Hospital	Oklahoma City	Oklahoma
United States	Orange County Heart Institute	Orange	California
United States	Swedish Medical Center	Seattle	Washington
United States	VA Beach General	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Compliance With Completing 6MWT Through a Wearable Defibrillator.	Observe Compliance with completing weekly 6MWT	Up to 12-14 Weeks of WCD use
Secondary	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