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AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
RecruitingObservational study
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Who can join
Ages 22 and older · All sexes
Full eligibility 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
About the 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.
What is being tested
- Hearo App (device)
Sponsor: Cordio Medical · Participants: 500 · Started: Feb 11, 2022
Contact the study team
- Bill Tobin · Phone: (203) 852-8900
Official record on ClinicalTrials.gov — NCT06378632
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.