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1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCD/Cardiox FDS/TEE testing | Experimental | All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiox FDS | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35249 | United States | ||
| Heart and Vascular Center of Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9576637 | Background | Karttunen V, Ventila M, Hillbom M, Salonen O, Haapaniemi H, Kaste M. Dye dilution and oximetry for detection of patent foramen ovale. Acta Neurol Scand. 1998 Apr;97(4):231-6. doi: 10.1111/j.1600-0404.1998.tb00643.x. | |
| 15358955 | Background | Spencer MP, Moehring MA, Jesurum J, Gray WA, Olsen JV, Reisman M. Power m-mode transcranial Doppler for diagnosis of patent foramen ovale and assessing transcatheter closure. J Neuroimaging. 2004 Oct;14(4):342-9. doi: 10.1177/1051228404268743. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 8, 2014 | |
| Unrelease | Yes | |
| Release | Jan 27, 2014 | |
| Reset | Mar 11, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 8, 2014 | Yes | |||
| Jan 27, 2014 |
| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| ID | Term |
|---|---|
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
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|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| UCLA Medical Center | Los Angeles | California | 90095 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Riverside Methodist Hospital | Columbus | Ohio | 43214 | United States |
| Swedish Hospital | Seattle | Washington | 98122 | United States |
| Mar 11, 2014 |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |