An observational study in Heart Failure, sponsored by Cordio Medical. Recruiting at 45 sites in 3 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Cordio Medical · Observational
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.
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.
Outpatient clinics
Major Inclusion Criteria:
At least one of the following:
Major Exclusion Criteria:
No intervention - only data collection
Heart Failure Events (HFEs)
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period
Time frame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient
Plan to share: No
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Cordio Medical