Cardiox Shunt Detection Technology Study

Patent Foramen Ovale Clinical Trial

Official title:

FDS-0004 Cardiox Shunt Detection Technology Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01333761
• Other study ID #: FDS-0004
• Status: Terminated
• Phase: Phase 3
• First received: March 31, 2011
• Last updated: January 8, 2013
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2013
• Source: Cardiox Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foramen Ovale, Patent
• Patent Foramen Ovale

Intervention

Device:
• Cardiox 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.

Locations

Country	Name	City	State
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Tufts Medical Center	Boston	Massachusetts
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	UCLA Medical Center	Los Angeles	California
United States	Columbia University Medical Center	New York	New York
United States	Heart and Vascular Center of Arizona	Phoenix	Arizona
United States	Swedish Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Cardiox Corporation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Karttunen V, Ventilä 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS		1 day
Secondary	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