Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases (CADENCE)

AUM Cardiovascular

Status: Withdrawn

Conditions: Coronary Artery Disease

Treatments: Device: CADence System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01584622

AUM1040-001

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind