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Clinical Trial Summary

This study is designed as a prospective study to capture data for evaluating the repeatability and reproducibility of the CADence™ System. The study will be conducted at 3 different study sites using 6 CADence™ systems. Each subject will be tested 4 separate times by 2 different operators at each site and will be tested at all 3 site locations in order to accomplish this evaluation. The study will enroll a total of at least 24 CADence positive patients and at least 24 CADence negative patients.

Clinical Trial Description

The CADence™ system is comprised of a digital stethoscope used to record cardiac (heart) sounds, with integrated sensor used to record electrical activity of the heart (ECG), a single‐use patient booklet, and the CADence™ Software application. CADence™ Software is a clinical decision support tool for the noninvasive functional evaluation of patients presenting with chest pain and at least two coronary artery disease risk factors that is intended to aid a qualified clinician's analysis of normal/physiological and pathological heart murmurs and in ruling out significant coronary disease as a cause for these symptoms of cardiovascular disease, utilizing simultaneous recording of cardiac sounds and ECG.

The purpose of this study is to assess the precision of the CADence site using multiple operators, cadence systems and clinical sites. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03793049
Study type Observational
Source AUM Cardiovascular, Inc.
Contact Marie Johnson, PhD
Phone 6127992511
Status Not yet recruiting
Start date January 12, 2019
Completion date January 31, 2019

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