Coronary Artery Disease Clinical Trial
Official title:
Repeatability and Reproducibility of the CADence™System
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.
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.
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