An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Cordio Medical
- Enrollment
- 500
- Locations
- 44
- Primary Endpoint
- Heart Failure Events (HFEs)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 22 or greater
- •Diagnosed with Symptomatic Chronic Heart Failure \[NYHA II-IVa (ambulatory)\]
- •At least one of the following:
- •One ADHF hospitalization in the last 12 months
- •One unplanned IV/SC diuretic administration in the last 6 months
- •Two unplanned IV/SC diuretic administrations in the last 12 months
- •NTProBNP \>500 pg/ml
- •Clinically stable HF according to investigator discretion
- •Willing to participate as evidenced by signing the written informed consent.
Exclusion Criteria
- •Unable to comply with daily use of the App,
- •Has had a major cardiovascular event within 3 months prior to enrolment.
- •Had a Cardiac Resynchronization Therapy Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
- •Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.
- •Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
- •Was treated for a significant COPD
Outcomes
Primary Outcomes
Heart Failure Events (HFEs)
Time Frame: EOS is defined as when a total of at least 78 first usable and CEC-adjudicated HFEs have occurred or up-to 24 months per patient
Until the end of the study, each participant will be assigned to one of the following event outcomes: 1. Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period 2. Having no Heart Failure Event (HFE) during the entire CORE period