AN INTERNATIONAL, OBSERVATIONAL, BLINDED STUDY TO ASSESS THE PERFORMANCE OF THE CORDIO HEARO SYSTEM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hearo App.
- Who it may be relevant to
- Registry conditions: Heart Failure. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Israel, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System
Overview
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.
Interventions
- Device Hearo App
No intervention - only data collection
Primary outcome measures
- 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]
Eligibility criteria
Major 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.
Major 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/1.73.
- Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
- Was treated for a significant COPD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 37 centers
- Eastern Shore Research Institute — Fairhope
- UC San Diego Health — La Jolla
- VA Loma Linda Healthcare System — Loma Linda
- VA San Diego — San Diego
- University of California, San Francisco — San Francisco
- Kaiser Permanente San Francisco — San Francisco
- Nature Coast Clinical Research — Crystal River
- Jacksonville Center for Clinical Research — Jacksonville
- … and 29 more centers
Israel · 7 centers
- University Hospital Samson Assuta Ashdod — Ashdod
- Assuta Be'er Sheva Medical Center — Beersheba
- Rambam Medical Center — Haifa
- Shaare Zedek Medical Center — Jerusalem
- Galiee Medical Center — Nahariya
- Tel Aviv Sourasky (Ichilov) Medical Center — Tel Aviv
- Poriya Medical Center — Tiberias
Spain · 1 center
- Hospital Universitari Germans Trias i Pujol — Badalona
Identifiers
NCT: NCT06378632 · CLN0011 DETECT-HF