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Cardiox Shunt Detection Technology Study

Primary Purpose

Patent Foramen Ovale

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cardiox FDS
Sponsored by
Cardiox Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patent Foramen Ovale focused on measuring right to left cardiac shunt finding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama, Birmingham
  • Heart and Vascular Center of Arizona
  • UCLA Medical Center
  • Tufts Medical Center
  • Columbia University Medical Center
  • Riverside Methodist Hospital
  • Swedish Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TCD/Cardiox FDS/TEE testing

Arm Description

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

Outcomes

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
To establish the safety of the Cardiox FDS device by tracking number of participants with adverse events related to Cardiox FDS

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

Full Information

First Posted
March 31, 2011
Last Updated
January 8, 2013
Sponsor
Cardiox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01333761
Brief Title
Cardiox Shunt Detection Technology Study
Official Title
FDS-0004 Cardiox Shunt Detection Technology Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
1)new FDS device design 2)improved Valsalva procedure 3)improved headbands and earpads.
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiox Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Foramen Ovale
Keywords
right to left cardiac shunt finding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TCD/Cardiox FDS/TEE testing
Arm Type
Experimental
Arm Description
All patients enrolled will be evaluated with TCD and Cardiox FDS and TEE for the presence of RTLS.
Intervention Type
Device
Intervention Name(s)
Cardiox FDS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Heart and Vascular Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Swedish Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9576637
Citation
Karttunen V, Ventila M, Hillbom M, Salonen O, Haapaniemi H, Kaste M. Dye dilution and oximetry for detection of patent foramen ovale. Acta Neurol Scand. 1998 Apr;97(4):231-6. doi: 10.1111/j.1600-0404.1998.tb00643.x.
Results Reference
background
PubMed Identifier
15358955
Citation
Spencer MP, Moehring MA, Jesurum J, Gray WA, Olsen JV, Reisman M. Power m-mode transcranial Doppler for diagnosis of patent foramen ovale and assessing transcatheter closure. J Neuroimaging. 2004 Oct;14(4):342-9. doi: 10.1177/1051228404268743.
Results Reference
background

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Cardiox Shunt Detection Technology Study

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