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

S

Samsung

Status

Terminated

Conditions

Congestive Heart Failure

Treatments

Device: Samsung LABGEO IVD-A20 CHF Test

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

191 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

191 participants in 3 patient groups

CHF-confirmed subjects
Description:
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.
Treatment:
Device: Samsung LABGEO IVD-A20 CHF Test
Subjects with potentially co-morbidities
Description:
non-CHF subjects 21 years or greater, with potentially confounding comorbidities such as diabetes, renal insufficiency, hypertension and chronic obstructive pulmonary disease (COPD).
Treatment:
Device: Samsung LABGEO IVD-A20 CHF Test
Apparently healthy subjects
Description:
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.
Treatment:
Device: Samsung LABGEO IVD-A20 CHF Test

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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