Cordio HearO: Cordio HearO is a software medical device that remotely monitors Congestive Heart Failure (CHF) patients by detecting changes in the patients' recorded voice relative to a baseline. The system is comprised of a mobile application (or "app") that is deployed on a mobile platform, and a web-based portal that enables caregivers to manage their patients
Study summary
To determine the usability and technical aspects of Cordio HearO™
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Major inclusion Criteria:
1. Adults patients
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 administration in the last 12 months
4. NTProBNP \>500 pg/ml or BNP\*\> 150 pg/ml at screening visit
4. Clinically stable HF
5. Willing to participate as evidenced by signing the written informed consent.
6. Male or non-pregnant female patient (pre-menopausal women will confirm verbally).
Major exclusion Criteria:
1. Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.
2. Unable to comply with daily use of the App
3. Major cardiovascular event
4. Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
5. Has estimated Glomerular Filtration Rate (eGFR) \< 30 ml/min/1.73 meter square (Cockroft-Gault formula).
6. Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.
Primary outcome measure(s)
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users. — 2 years The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction.
Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome
Patient Usability success defined as: 2. Total Compliance — 2 Years The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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