Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting
Stopped early
Conditions studied: Congestive Heart Failure
In brief
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
Key facts
- Study ID
- NCT02107495
- Run by
- Samsung Electronics
- People needed
- 191
- Starts
- 2014-03-01
- Expected to finish
- 2015-02-01
- Last updated by the study team
- 2016-04-19
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- CHF Subjects: 21 years of age or greater, with clinically confirmed CHF or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.
- Subjects with Potentially confounding comorbidities: Non-CHF subjects 21 years of age or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD)
- Healthy Subjects: apparently healthy subjects greater than 45 years of age, with no prior history of cardiac-related disease.
You may not qualify if…
- Apparently healthy subjects with a history of MI, CHF or other cardiac-related disease;
- Subjects with acute decompensated heart failure currently on nesiritide therapy;
- Subjects having participated in another experimental drug, biologic, or invasive device study within 30 days prior to signing informed consent for this study, or enrolled concurrently in any other investigative study; and
- Subjects unable to or refusing to provide written informed consent.
Where it is running
- University of Maryland — Baltimore, Maryland, United States
- Minneapolis Medical Research Foundation — Minneapolis, Minnesota, United States
- Manassas Clinical Research Center — Manassas, Virginia, United States
Full record on ClinicalTrials.gov
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