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N/ARecruiting

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

Sponsored by Cordio Medical

About this study

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.

Where this study is enrolling (37)

Show all 37 locations
Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.