NCT04169815

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,370 (actual)
• Sponsor: Beckman Coulter, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Access Immunodiagnostic Products	Access Natriuretic Peptide Assay

Timeline

• Start date: 2019-11-20
• Primary completion: 2022-05-31
• Completion: 2022-09-30
• First posted: 2019-11-20
• Last updated: 2023-02-14

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study