An observational study in Chronic Heart Failure, sponsored by Cordio Medical. Active, not recruiting at 8 sites in 2 countries. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Cordio Medical · Observational
To determine the usability and technical aspects of Cordio HearO™
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
Adult clinical stable patients with NYHA II-IVa (ambulatory)
Major inclusion Criteria:
At least one of the following:
Major exclusion Criteria:
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
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
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
Time frame: 2 years
Patient Usability success defined as: 2. Total Compliance
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.
Time frame: 2 Years
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Cordio Medical