Access Natriuretic Peptide Assay(s) Pivotal - Emergency Department Subject Enrollment and Specimen Collection

Study Overview
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Brief Summary
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The purpose of the pivotal study is to collect blood specimens and clinical data from patients suspected of having Heart Failure (HF), which will be tested at a future date on Natriuretic Peptide assay(s) to validate diagnostic cutoffs and assess HF severity.

Detailed Description
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A prospective clinical sample collection and future natriuretic peptide testing will be conducted in an emergency department only population. Patients presenting to the Emergency Department (ED) with signs and symptoms of acute heart failure will be approached for enrollment. Clinical and laboratory data will be collected to establish product performance and clinical concordance to adjudicated clinical diagnosis. Approximately 1800 evaluable subjects at geographically dispersed sites in the US will be enrolled in the study. Sample collection and testing of clinical samples with the Access Natriuretic Peptide assay will be performed under two separate protocols

Official Title
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Pivotal Evaluation of the Access Natriuretic Peptdie Assay(s) as an Aid in the Diagnosis and Assessment of Severity of Acute Heart Failure - Emergency Department Subject Enrollment and Specimen Collection

Conditions
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Heart Failure

Intervention / Treatment
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* Diagnostic Test: Access Immunodiagnostic Products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent obtained Adult aged 21 years or older Presenting with a clinical suspicion of acute HF Subject clinical history available for review by Sponsor or delegates and FDA or other regulatory agencies Exclusion Criteria: Dyspnea clearly not secondary to HF (e.g. primary lung disease or chest trauma) Stage 4 or 5 Chronic Kidney Disease (CKD) Chronic dialysis Participation in a clinical study that may interfere with participation in this study Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ED Setting<br>An acute HF population enrolled at the emergency department. Testing of clinical samples will be performed with the Access natriuretic peptide assay. | Diagnostic Test: Access Immunodiagnostic Products<br>* Access Natriuretic Peptide Assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity of the future Natriuretic Peptide Assay(s) | Establish the performance of the future Natriuretic Peptide assay(s) against the adjudicated diagnosis. | Single blood draw upon study entry at day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Failure Severity Assessment | Demonstrate that the Access Natriuretic Peptide Assay may be used for assessment of heart failure severity. | Single blood draw upon study entry at day 1 and two remote follow up visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Natriuretic Peptide