Evaluation of CSF-3 in Performing ECG (ECG)

A Prospective Study for Evaluating the Safety and Performance of CSF-3 ECG Lead-I, HR and PR When Compared to ECG Holter

CSF-3 is a wrist-worn medical device similar to a watch. It is designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings, using off-the-shelf ECG and unique PPG chipsets with proprietary algorithms. ECG and PPG are the two primary technologies for measuring heart rate. ECG measures the bio-potential generated by electrical signals that control the expansion and contraction of heart chambers, while PPG uses light-based technology to sense the rate of blood flow as controlled by the heart's pumping action.

Study Overview

• Status: Completed
• Conditions: Healthy; ECG
• Intervention / Treatment: Device: CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings

Detailed Description

The proposed clinical study is a prospective, open, single-center study to evaluate the performance and accuracy of the ECG and heart rate calculation of the CSF-3 investigational Device.

Subjects will be screened by the Principal Investigator. Subjects who meet the study's enrolment criteria will be recruited and fitted with an FDA cleared ECG Holter, and with the investigational Device (CSF-3).

At least 40 eligible subjects will be enrolled in a single center. Data collected from the subjects during the study will be included in the overall performance analysis of the ECG output. Subjects will perform an ECG and CSF-3 Device simultaneously Subjects will remain connected to both the ECG Holter and the CSF-3 Device at the study site for at least 7 minutes duration. The ECG and Holter will be stopped simultaneously. Both recordings data (ECG and CSF-3) will be uploaded and then synchronized offline using a dedicated and validated tool.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55102
      • Fairview Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 21 years old
• Able and willing to understand and sign the informed consent and follow instructions
• Screening ECG results of Sinus Rhythm
• Wrist size 14 cm (5.5"), Max 20 cm (7.8")

Exclusion Criteria:

• Subjects who are currently enrolled in other clinical investigation
• Subjects diagnosed with a cardiac disorder or any cardiac symptoms
• Subjects with SNR < 100
• Subjects with ECG quality range > 1 and < 30
• Individuals with electrical pacing by a pacemaker
• Subjects who are pregnant or breastfeeding
• Subjects with callous on the index finger or thumb (at fingerprint area)
• Subjects with active wound, prior soft tissue injury or skin conditions at the measurement location Sensitivity to the device material or ECG patches
• Subjects with tremors or otherwise unable to remain still for 15 minutes
• Subjects without two hands and sufficient fingers to complete the study
• Subjects unable to participate based upon investigator discretion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: CSF-3 and ECG Holter; At least 40 healthy subjects with no relevant or cardiac medical history and negative cardiac symptoms. Subjects will perform an ECG spot-check measurement using the CSF-3 Device while simultaneously being connected to an ECG Holter. Recording duration for both ECG Holter and CSF-3 device will be at least 7 minutes.

Device: CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings; The subjects will be connected to an ECG Holter, and an investigational Device will be placed simultaneously on the subject's wrist. All subjects in this phase will be asked to participate in a single continuous data recording measurement for seven (7) minutes; Other Names: FDA cleared ECG Holter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF-3 efficacy in ECG detection	Performance endpoint is defined as the ability of CSF-3 to detect beat-by beat Heart Rate in ECG signal with a sensitivity of no less than 96%, considering a false detection rate of not higher than 2%, and PPV of 80%.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CSF-3 HR calculation	Performance endpoint is defined as the calculation of average Heart Rate with ARMS error<3BPM	6 months

Collaborators and Investigators

• Sponsor: CardiacSense Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2022
• Primary Completion (ACTUAL): February 1, 2023
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: October 19, 2022
• First Submitted That Met QC Criteria: October 19, 2022
• First Posted (ACTUAL): October 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CSF-3 ECG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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