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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cordio | Cordio R&D database to develop the Cordio System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cordio System | Device | App, cloud and web device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Usability | Questionnaires with SUS scale and specific app questions in order to assess the app usability | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| SADE Endpoint | Demonstration of the safe use of the device by overall incidence of device related adverse events. | 2 years |
Inclusion Criteria:
Exclusion Criteria:
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Patients with NYHA 2-3. All patients must meet eligibility criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ronit Haviv, PhD | Contact | 972-3-5467163 | ronit@cordio-med.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Recruiting | Ashkelon | Israel |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Clalit Bat Yam | Recruiting | Bat Yam | Israel |
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| Clalit Be'er Sheva | Recruiting | Beersheba | Israel |
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| Clalit Bet Shemesh | Recruiting | Bet Shemesh | Israel |
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| Shamir Medical Center | Recruiting | Be’er Ya‘aqov | 70300 | Israel |
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| Hillel Yaffe Medical Center | Recruiting | Hadera | Israel |
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| Galilee Medical Center | Recruiting | Nahariya | Israel |
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| Rabin Medical Center | Recruiting | Petah Tikva | Israel |
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