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Cardiox Shunt Detection Technology Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01333761
Recruitment Status : Terminated (1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.)
First Posted : April 12, 2011
Last Update Posted : January 9, 2013
Information provided by (Responsible Party):
Cardiox Corporation

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.

Condition or disease Intervention/treatment Phase
Patent Foramen Ovale Device: Cardiox FDS Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FDS-0004 Cardiox Shunt Detection Technology Study
Study Start Date : April 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: TCD/Cardiox FDS/TEE testing
All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.
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.

Primary Outcome Measures :
  1. 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 [ Time Frame: 1 day ]
  2. To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt [ Time Frame: 1 day ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01333761

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United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35249
United States, Arizona
Heart and Vascular Center of Arizona
Phoenix, Arizona, United States, 85006
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
United States, Washington
Swedish Hospital
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Cardiox Corporation
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Responsible Party: Cardiox Corporation Identifier: NCT01333761    
Other Study ID Numbers: FDS-0004
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: January 9, 2013
Last Verified: January 2013
Keywords provided by Cardiox Corporation:
right to left cardiac shunt finding
Additional relevant MeSH terms:
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Foramen Ovale, Patent
Heart Septal Defects, Atrial
Heart Septal Defects
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities