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To determine the usability and technical aspects of Cordio HearOâ„¢
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 2 Years |
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Major inclusion Criteria:
Adults patients
Diagnosed with Symptomatic Chronic Heart Failure [NYHA II-IVa (ambulatory)]
At least one of the following:
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:
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Adult clinical stable patients with NYHA II-IVa (ambulatory)
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| Name | Affiliation | Role |
|---|---|---|
| Ronit Haviv, PhD | Cordio Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurker Family Medicine | South Windsor | Connecticut | 06074 | United States | ||
| C&R Research Services |
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| Cape Coral |
| Florida |
| 33904 |
| United States |
| C&R Research Services | Miami | Florida | 33176 | United States |
| C&R Research Services | Miami | Florida | 33183 | United States |
| Lake County Med Grp | Athens | Georgia | 31024 | United States |
| Barzilai Medical Center- Cardiology | Ashkelon | Israel |
| Heart Failure Clinic - Clallit Be'er Sheva | Beersheba | Israel |
| Rabin Medical Center - Cardiology- CHF | Petah Tikva | 49100 | Israel |