LifeVest Trends Validation Protocol

Completed

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT02149290

Run by

Zoll Medical Corporation

People needed

198

Starts

2014-02-01

Expected to finish

2017-12-01

Last updated by the study team

2020-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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