Cardiox Shunt Detection Technology Study
- Conditions
- Patent Foramen Ovale
- Interventions
- Device: Cardiox FDS
- Registration Number
- NCT01333761
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 71
- Eighteen (18) years of age or older
- Informed consent documentation understood and signed
- Planned or completed TEE study within the last 12 months
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TCD/Cardiox FDS/TEE testing Cardiox FDS All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.
- Primary Outcome Measures
Name Time Method 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 1 day To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS 1 day
- Secondary Outcome Measures
Name Time Method To evaluate the Cardiox FDS against TEE for sensitivity for the detection of RTLS and specificity for the detecting the absence of a shunt 1 day
Trial Locations
- Locations (7)
Heart and Vascular Center of Arizona
🇺🇸Phoenix, Arizona, United States
University of Alabama, Birmingham
🇺🇸Birmingham, Alabama, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Swedish Hospital
🇺🇸Seattle, Washington, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States