An INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY to ASSESS the PERFORMANCE of the CORDIO HEARO SYSTEM (DETECT-HF)

Cordio Medical

Status: Enrolling

Conditions: Heart Failure

Treatments: Device: Hearo App

Study type: Observational

Funder types: Industry

Identifiers

NCT06378632

CLN0011 DETECT-HF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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