Cardiox Shunt Detection Technology Study

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