Expired Study
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Oklahoma City, Oklahoma 73120


Purpose:

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).


Study summary:

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.


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


NCT ID:

NCT02149290


Primary Contact:

Study Director
Steven J Szymkiewicz, MD
Zoll Medical Corporation


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73120
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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