Cardiox Shunt Detection Technology Study

Status:	Terminated
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	10/14/2017
Start Date:	April 2011
End Date:	July 2012

FDS-0004 Cardiox Shunt Detection Technology Study

The CARDIOX Flow Detection System is designed to detect the presence of indocyanine green
(ICG) dye in the blood and is being investigated to establish its efficacy in detecting the
presence of right to left cardiac shunt (RTLS). The CARDIOX system will be compared against
transesophageal echocardiography (TEE) for sensitivity and specificity, as well as
transcranial doppler (TCD) for positive percent agreement and negative percent agreement.

Inclusion Criteria:

- Eighteen (18) years of age or older

- Informed consent documentation understood and signed

- Planned or completed TEE study within the last 12 months

Exclusion Criteria:

- Subjects with a known allergy or sensitivity to Indocyanine Green Dye (ICG) or to
Iodide Contrast Dye or Iodides

- Pregnant women or nursing mothers

- Subject unable or unwilling to understand and sign the informed consent

- Subject scheduled for radioactive iodine uptake test (Thyroid test) within 7 days of
post screening

- Subjects that have poor renal function such as subjects on dialysis, subjects with a
recent history of creatinine > 2.0 or subjects currently being followed by a
nephrologist

We found this trial at

sites

Riverside Methodist Hospital

3535 Olentangy River Rd
Columbus, Ohio 43214

(614) 566-5000