Status:
UNKNOWN
COMMUNITY STUDY- A Study to Collect Information for the Cordio System
Lead Sponsor:
Cordio Medical
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
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 vali...
Eligibility Criteria
Inclusion
- Age \> 18 years.
- Symptomatic Heart Failure Patient.
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient.
Exclusion
- Subject who, in the Investigator's opinion, unable to comply with the daily use of the App due to mental disorders (e.g., depression, dementia).
- Patient who has had a major cardiovascular event (e.g., myocardial infraction, stroke) within 3 months prior to screening visit.
- Patient with severe alcohol or drug use.
- Psychological instability, inappropriate attitude or motivation.
- Patient with life threatening debilitating disease other than cardiac.
- Subject currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
Key Trial Info
Start Date :
October 20 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2022
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT03438799
Start Date
October 20 2015
End Date
April 1 2022
Last Update
April 27 2021
Active Locations (8)
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1
Barzilai Medical Center
Ashkelon, Israel
2
Clalit Bat Yam
Bat Yam, Israel
3
Clalit Be'er Sheva
Beersheba, Israel
4
Clalit Bet Shemesh
Bet Shemesh, Israel