for people ages 22 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around
Principal Investigator
by Nicholas Wettersten, MD
Headshot of Nicholas Wettersten
Nicholas Wettersten



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.

Official Title

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio 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.


Heart Failure, Hearo App


For people ages 22 years and up

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


  • UC San Diego Health accepting new patients
    La Jolla California 92037 United States
  • VA San Diego accepting new patients
    San Diego California 92161 United States

Lead Scientist at UCSD

  • Nicholas Wettersten, MD
    Assistant Professor Of Clinical, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 48 research publications. Research interests: Biomarkers · Heart Failure · Kidney Disease · Cardiorenal Syndrome


accepting new patients
Start Date
Completion Date
Cordio Medical
Study Type
Expecting 500 study participants
Last Updated