Overview
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.
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.
Eligibility
Major Inclusion Criteria:
- Age 22 or greater
- Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
- At least one of the following:
- One ADHF hospitalization in the last 12 months
- One unplanned IV/SC diuretic administration in the last 6 months
- Two unplanned IV/SC diuretic administrations in the last 12 months
- NTProBNP >500 pg/ml
- Clinically stable HF according to investigator discretion
- Willing to participate as evidenced by signing the written informed consent.
Major Exclusion Criteria:
- Unable to comply with daily use of the App,
- Has had a major cardiovascular event within 3 months prior to enrolment.
- Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
- Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73.
- Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
- Was treated for a significant COPD