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OpenTrials
Active, Not Recruiting

NCT Number: NCT05876533

R&D Study to Evaluate Cordio's Usability and to Collect Patient Speech Utterances

To determine the usability and technical aspects of Cordio HearO™

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barzilai Medical Center- Cardiology, Ashkelon, Israel

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About this study

The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.

The recordings data will also be used for algorithm improvement

Who can participate

Healthy volunteers accepted: No

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

Major inclusion Criteria:

  • Adults patients
  • 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 administration in the last 12 months
  • NTProBNP >500 pg/ml or BNP*> 150 pg/ml at screening visit
  • Clinically stable HF
  • Willing to participate as evidenced by signing the written informed consent.
  • Male or non-pregnant female patient (pre-menopausal women will confirm verbally).

Major exclusion Criteria:

  • Not able to read in Hebrew, Russian, Arabic, English and/or Spanish.
  • Unable to comply with daily use of the App
  • Major cardiovascular event
  • Had a Cardiac Resynchronization Device (CRT) implanted or upgrading ≤ 1 month prior to screening visit.
  • Has estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73 meter square (Cockroft-Gault formula).
  • Is likely to undergo heart transplantation/ LVAD within 6 months of Screening Visit.

Treatment and study plan

Cordio HearO

Device

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

Primary outcomes

  1. Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.

    Time frame: 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

  2. Patient Usability success defined as: 2. Total Compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cordio Medical

Industry

Registry information

Official study title

An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 25, 2023
Registry last updated
Dec 31, 2024

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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