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Cardiox Shunt Detection Technology Study

This study has been terminated.
(1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.)
Sponsor:
Information provided by (Responsible Party):
Cardiox Corporation
ClinicalTrials.gov Identifier:
NCT01333761
First received: March 31, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Patent Foramen Ovale
Device: Cardiox FDS
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FDS-0004 Cardiox Shunt Detection Technology Study

Further study details as provided by Cardiox Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: April 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333761

Locations
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
  More Information

Publications:
Responsible Party: Cardiox Corporation
ClinicalTrials.gov Identifier: NCT01333761     History of Changes
Other Study ID Numbers: FDS-0004
Study First Received: March 31, 2011
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cardiox Corporation:
right to left cardiac shunt finding

Additional relevant MeSH terms:
Foramen Ovale, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Heart Septal Defects
Heart Septal Defects, Atrial

ClinicalTrials.gov processed this record on November 27, 2014