Evaluation of the Samsung LABGEO IVD-A20 CHF Test in a Point-of-Care Setting

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

Total Enrollment

191 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Congestive Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CHF-confirmed subjects

Subjects 21 years of age or greater with clinically confirmed heart failure or have presented to the clinical site with signs, symptoms and/or risk factors suggestive of heart failure.

Samsung LABGEO IVD-A20 CHF Test

Intervention Type DEVICE

Subjects with potentially co-morbidities

non-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD).

Samsung LABGEO IVD-A20 CHF Test

Intervention Type DEVICE

Apparently healthy subjects

Apparently healthy subjects (meeting inclusion criteria) greater than 45 years of age, with no prior history of myocardial infarction (MI), acute coronary syndrome (ACS) congestive heart failure (CHF) or any other cardiac-related disease.

Samsung LABGEO IVD-A20 CHF Test

Intervention Type DEVICE

Interventions

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Samsung LABGEO IVD-A20 CHF Test

Intervention Type DEVICE

Other Intervention Names

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LABGEO IVD-A20 CHF Test, A20 CHF Test,

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes