Cardiox Shunt Detection Technology Study

Phase 3TerminatedNCT01333761

Cardiox Corporation71 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Patent Foramen Ovale

Interventions

Cardiox FDSDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

University of Alabama, Birmingham

Birmingham, Alabama, United States

Heart and Vascular Center of Arizona

Phoenix, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

Tufts Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

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 Outcomes

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

Data from ClinicalTrials.gov

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