Cardiox Shunt Detection Technology Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Patent Foramen Ovale

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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TCD/Cardiox FDS/TEE testing

All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.

Group Type EXPERIMENTAL

Cardiox FDS

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No