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

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

Study Overview

• Status: Completed
• Conditions: Atrium; Fibrillation
• Intervention / Treatment: Device: CS1 & heart monitor

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%.

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Tel Aviv, Israel, 62431
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: CS1 & heart monitor; Daily activities while wearing the investigational device as well as the control device
Active Comparator: 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	Device: CS1 & heart monitor; Daily activities while wearing the investigational device as well as the control device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Safety of CardicacSense1	Incidence and severity of device related Adverse Events	24 to 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Ease of use of the CardiacSense1 device based on user questionnaire	24 to 48 hours

Collaborators and Investigators

• Sponsor: CardiacSense Ltd.
• Investigators: Principal Investigator: Ofer Havakuk, MD, PhD, Department of Cardiology, Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): November 25, 2019
• Study Completion (Actual): June 9, 2020

Study Registration Dates

• First Submitted: February 20, 2018
• First Submitted That Met QC Criteria: March 18, 2018
• First Posted (Actual): March 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: CL00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No individual data will be shared. Data analysis will include comparative overall data between investigational device and control device, as well as usability data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No