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Assessing the performance of the HearO system for heart failure patients

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

Observational Cordio Medical · NCT06378632

This study is testing the HearO system to see how well it works for heart failure patients by collecting their daily recordings over two years.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages22 Years and up
SexAll
SponsorCordio Medical Industry-sponsored
Locations45 sites (Fairhope, Alabama and 44 other locations)
Trial IDNCT06378632 on ClinicalTrials.gov

What this trial studies

This international, multicenter observational study aims to evaluate the performance of the HearO system by collecting daily recordings from patients diagnosed with symptomatic chronic heart failure. The study consists of a run-in period for baseline creation followed by a core period where patients will continue to submit recordings for up to 24 months. The data collected will be retrospectively analyzed to determine the system's sensitivity and user performance metrics. The study is non-interventional and focuses on real-world patient experiences.

Who should consider this trial

Good fit: Ideal candidates include adults aged 22 or older with symptomatic chronic heart failure who have experienced recent hospitalizations or significant diuretic use.

Not a fit: Patients who are unable to comply with daily app usage or have had recent major cardiovascular events may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the monitoring and management of heart failure, leading to improved patient outcomes.

How similar studies have performed: While similar observational studies have been conducted, the specific use of the HearO system in this context is relatively novel.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Fairhope, Alabama and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart Failure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.