Patent Foramen Ovale
Conditions
Keywords
right to left cardiac shunt finding
Brief summary
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.
Interventions
DEVICECardiox FDS
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.
Sponsors
Cardiox Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed