An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Cordio Medical
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.
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 A…
Interventions
- DeviceHearo App
No intervention - only data collection
Locations (45)
- Eastern Shore Research InstituteFairhope, Alabama
- UC San Diego HealthLa Jolla, California
- VA Loma Linda Healthcare SystemLoma Linda, California
- VA San DiegoSan Diego, California
- University of California, San FranciscoSan Francisco, California
- Kaiser Permanente San FranciscoSan Francisco, California