Angiographic Comparison in an Observational Study of CADence (The AMBIENCE Study)



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:41 - Any
Updated:7/13/2016
Start Date:May 2016
End Date:June 2016

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this non-significant risk study is to collect performance information
regarding the use of the CADence system under normal conditions of use. This is a
prospective, multi-center study to capture information on CADence agreement with coronary
angiograms, on subjects who are already scheduled for coronary angiography.


Inclusion Criteria:

- Age >40 years

- Clinical indication for coronary angiogram

- Willing and able to give informed consent

Exclusion Criteria:

- Body Mass Index (BMI) <18.5 or >40

- Prior bypass surgery or coronary stenting

- Presence of pacemaker/defibrillator

- Presence of artificial valve

- Presence of obvious cyanotic or pre-diagnosed congenital heart defect and coarctation
of the aorta

- Presence of murmurs, including valve lesions, ventricular septal defects and
arteriovenous fistulae

- Presence of moderate-severe valve disease

- Left Ventricular Assist Device (LVAD)

- Presence of scars on the site thorax areas

- Participation in trial within 30 days prior to collecting CADence data except
participation in registry studies.

- Asthma or chronic obstructive pulmonary disease (COPD) with active wheezing

- Inability to lie in supine position

- Heart Transplant
We found this trial at
2
sites
MedStar Union Memorial Hospital
Baltimore, Maryland 21218
Principal Investigator: John Wang, MD
Phone: 443-278-9170
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Baltimore, MD
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St. Joseph's Hospital
St. Paul, Minnesota 55102
Principal Investigator: Carmello Panetta, MD
Phone: 651-471-2684
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St. Paul, MN
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