Cardiox Shunt Detection Technology Study

Cardiox

Status and phase: Terminated; Phase 3

Conditions: Patent Foramen Ovale

Treatments: Device: Cardiox FDS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01333761

FDS-0004

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

TCD/Cardiox FDS/TEE testing

Experimental group

Description:

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

Treatment:

Device: Cardiox FDS