Status:
COMPLETED
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
Lead Sponsor:
CardiacSense Ltd.
Conditions:
Atrium; Fibrillation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation. The clinical study is intended to estab...
Detailed Description
The clinical study is intended to establish the efficacy and safety of the CardiacSense1 wearable device intended to monitor and detect heart arrhythmia, specifically atrial fibrillation (A-Fib). Stud...
Eligibility Criteria
Inclusion
- Age of eighteen (18) year and above
- Diagnosed with atrial fibrilation (Permanent of persistent), or healthy participants able to and willing to sign the informed consent form For control group-no known cardiac problems
Exclusion
- Subjects who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the subject's participation in this study.
- Subjects with low perfusion as indicated by the watch
- Women who are pregnant or breastfeeding
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2020
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03477734
Start Date
February 20 2019
End Date
June 9 2020
Last Update
July 21 2020
Active Locations (2)
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1
Rambam Medical Center
Haifa, Israel
2
Sourasky Medical Center
Tel Aviv, Israel, 62431