Coronary Artery Disease
Conditions
Brief summary
The purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.
Interventions
DEVICECADence System
Non-invasive detection of \> or equal to 50% stenosis in any of the major coronary arteries.
Sponsors
AUM Cardiovascular, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Willing and able to give informed consent * Indicated for angiography evaluation.
Exclusion criteria
* Pregnant or nursing * Presence of pacemaker/defibrillator * Presence of artificial valve * Presence of severe valve disease * Presence of congenital heart defect * Left Ventricular Assist Device (LVAD) * Presence of a bypass graft * Presence of scars on the site thorax areas * Coarctation of the aorta * Participation in trial within 30 days prior to collecting CADenceTM data * Asthma with wheezing * Inability to lie flat in the supine position * Acute STEMI * Heart Transplant * Recent Cocaine Use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree. | within three months | The CADence System will be considered to have demonstrated effectiveness in detecting greater than or equal to 50% coronary artery stenosis anywhere in the coronary tree if the estimated sensitivity as compared to angiography is statistically higher than 70%. |
Countries
United States
Outcome results
None listed