Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases

AUM Cardiovascular, Inc.7 sites in 1 countryJuly 2012

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: AUM Cardiovascular, Inc.
Locations: 7
Primary Endpoint: Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

February 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AUM Cardiovascular, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.

Time Frame: 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%.