Stopped: 1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.
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.
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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
Timeframe: 1 day
To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS
Timeframe: 1 day