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AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM — DETECT-HF  

Heart Failure Clinical Trial

Official title:
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

Clinical Trial Summary

Study Design: This is an international, multicenter, observational, non-interventional, prospective, blinded, single-arm, two-period study, to collect patient utterances that will be retrospectively analyzed to determine the sensitivity and UPNR of the HearO system.

Clinical Trial Description

Two periods: Run-In period will be a period in which patients will submit daily recordings, baseline creation Core period will be a period in which patients will be followed up and will continually submit daily recordings for up-to 24 months per patient or until End-of-Study (EOS), whichever comes first. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06378632
Study type Observational
Source Cordio Medical
Contact Bill Tobin
Phone (203) 852-8900
Email billt@ihcresearch.com
Status Recruiting
Phase
Start date February 11, 2022
Completion date December 1, 2024
View Details
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