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NCT Number: NCT06378632

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Samson Assuta Ashdod, Ashdod, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hearo App

Device

No intervention - only data collection

Primary outcomes

  1. 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:

    • Having at least one protocol-defined Heart Failure Event (HFE) in the CORE period
    • Having no Heart Failure Event (HFE) during the entire CORE period

Study contacts

Contact information is provided by the study sponsor or research team.

Bill Tobin

CONTACT

[email protected]

(203) 852-8900

Sponsors and collaborators

Lead sponsor

Cordio Medical

Industry

Registry information

Official study title

An International Multi-center Observational, Single-arm, Blinded Study to Assess the Performance of the Cordio HearO System

Acronym: DETECT-HF

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2024
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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