An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
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.
Major Inclusion Criteria:
Age 22 or greater
Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
At least one of the following:
Clinically stable HF according to investigator discretion
Willing to participate as evidenced by signing the written informed consent.
Major Exclusion Criteria:
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