Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
NCT ID: NCT03477734
Last Updated: 2020-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
53 participants
INTERVENTIONAL
2019-02-20
2020-06-09
Brief Summary
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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
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Detailed Description
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100 subjects, 50 (at least 30% of each gender) with A-fib and 50 without (at least 30% of each gender).
All subjects will be measured during at least 24 hours. Primary endpoint - A-Fib detection Control: Holter device will be the reference
For PPG analysis, each one hour will be considered as an event:
If A-Fib is present for more than accumulated 5 minutes in that specific hour then it shall be considered an "A-Fib hour" If A-fib was present for less than accumulated 5 minutes then it shall be considered a "Non-A-Fib hour".
For ECG analysis, each measurement of between 1-3 minutes will be considered an event.
If A-Fib is present at that specific measurement, then it shall be considered an "A-Fib event" If A-fib was not present at that specific measurement, then it shall be considered a "Non-A-Fib hour".
Sensitivity (true positive) is defined as the percentage of Holter defined "A-fib hours"/"A-Fib event" found by PPG/ECG.
The asked sensitivity is 90%. Specificity (true negative) is defined as the percentage of Holter defined "Non-A-fib hours"/"A-Fib event" found by PPG/ECG. The required specificity is 90%.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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CS1 & heart monitor - AF patients
Males and females diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed
CS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device
CS1 & heart monitor -Healthy volunteers
Males and females not diagnosed with atrial fibrillation will be fitted with the CardiacSense1 and Holter heart monitor for 24-48 hours while going about daily activities, results shall be compared and analysed
CS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device
Interventions
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CS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device
Eligibility Criteria
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Inclusion Criteria
* 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 with low perfusion as indicated by the watch
* Women who are pregnant or breastfeeding
18 Years
85 Years
ALL
Yes
Sponsors
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CardiacSense Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ofer Havakuk, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel
Locations
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Rambam Medical Center
Haifa, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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CL00001
Identifier Type: -
Identifier Source: org_study_id
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