AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM

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.

Eligibility

Major Inclusion Criteria:

1. Age 22 or greater
2. Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
3. At least one of the following:

   1. One ADHF hospitalization in the last 12 months
   2. One unplanned IV/SC diuretic administration in the last 6 months
   3. Two unplanned IV/SC diuretic administrations in the last 12 months
   4. NTProBNP \>500 pg/ml
4. Clinically stable HF according to investigator discretion
5. Willing to participate as evidenced by signing the written informed consent.

Major Exclusion Criteria:

1. Unable to comply with daily use of the App,
2. Has had a major cardiovascular event within 3 months prior to enrolment.
3. Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
4. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73.
5. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
6. Was treated for a significant COPD

Conditions2

Locations37 sites

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