Cardiox Shunt Detection Technology Study

Study Overview
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Brief Summary
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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.

Official Title
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FDS-0004 Cardiox Shunt Detection Technology Study

Conditions
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Patent Foramen Ovale

Intervention / Treatment
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* Device: Cardiox FDS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCD/Cardiox FDS/TEE testing<br>All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS. | Device: Cardiox FDS<br>* The Cardiox Shunt Detection system consists of a sensor placed in contact with the outer ear, similar to a finger probe used to detect oxygen levels in blood. Through an intravenous line, ICG (indocyanine green) at a dosage of 10 mg (2 mL of 5 mg/mL ICG solution) per test, is administered into the right or left antecubital fossa. The presence of ICG in the veins within the outer ear are detected, and the results are displayed on a monitor. All patients will also be evaluated with TCD and TEE for the presence of RTLS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Cardiox FDS system using TCD as a non-reference standard for positive percent agreement for accurately detecting a RTLS and negative percent agreement for accurately detecting the absence of RTLS |  | 1 day | 
| To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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right to left cardiac shunt finding