An observational study in Heart Failure, sponsored by Cordio Medical. Status unknown at 8 sites in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by Cordio Medical · Observational
This is a multi-center, observational, non-interventional, prospective, Single-arm, open study for database establishment for R\&D purposes. R\&D data will be analyzed retrospectively in order to validate algorithm efficacy.
The study will be conducted in the following settings: outpatinets clinics
Patients with NYHA 2-3. All patients must meet eligibility criteria.
Exclusion Criteria:
Cordio R\&D database to develop the Cordio System
Device: Cordio System
App, cloud and web device
R&D Database & Efficiency
Building R\&D recording database and retrospectively Cordio System needs to reach correlation between the system generated alerts to HF exacerbation
Time frame: 2 years
Usability
Questionnaires with SUS scale and specific app questions in order to assess the app usability
Time frame: 2 years
SADE Endpoint
Demonstration of the safe use of the device by overall incidence of device related adverse events.
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Cordio Medical