NCT03477734

Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: CardiacSense Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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 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

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). Study design as as follows: 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

• Atrium; Fibrillation

Interventions

Type	Name	Description
DEVICE	CS1 & heart monitor	Daily activities while wearing the investigational device as well as the control device

Timeline

• Start date: 2019-02-20
• Primary completion: 2019-11-25
• Completion: 2020-06-09
• First posted: 2018-03-26
• Last updated: 2020-07-21

Locations

2 sites across 1 country: Israel