Evaluation of CSF-3 in Performing ECG

Healthy Clinical Trial

— ECG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05591157
• Other study ID #: CSF-3 ECG
• Status: Completed
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: CardiacSense Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: February 1, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ECG
• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Fairview Health Services	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
CardiacSense Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	CSF-3 HR calculation	Performance endpoint is defined as the calculation of average Heart Rate with ARMS error<3BPM	6 months