Atrium; Fibrillation Clinical Trial
Official title:
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
NCT number | NCT03477734 |
Other study ID # | CL00001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 20, 2019 |
Est. completion date | June 9, 2020 |
Verified date | July 2020 |
Source | CardiacSense Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 establish the efficacy and safety of the CardiacSense1
wearable device intended to monitor and detect heart arrhythmia, specifically atrial
fibrillation (A-Fib) based on a comparison to a control device, which is an off-the-shelf
cleared Holter ECG device
Status | Completed |
Enrollment | 53 |
Est. completion date | June 9, 2020 |
Est. primary completion date | November 25, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa | |
Israel | Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
CardiacSense Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CardicacSense1 atrial fibrillation detection rate | Comparison of the number of atrial fibrillation sessions detected by reference comparing to PPG and ECG sensors in CardiacSense device. | 24 to 48 hours | |
Primary | Safety of CardicacSense1 | Incidence and severity of device related Adverse Events | 24 to 48 hours | |
Secondary | Usability | Ease of use of the CardiacSense1 device based on user questionnaire | 24 to 48 hours |
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