Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03477734
• Other study ID #: CL00001
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: June 9, 2020

Study information

• Verified date: July 2020
• Source: CardiacSense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrium; Fibrillation

Intervention

Device:
• CS1 & heart monitor
Daily activities while wearing the investigational device as well as the control device

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

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