Evaluation of CSF-3 in Performing ECG

NCT ID: NCT05591157

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-16
• Study Completion Date: 2023-02-01

Brief 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.

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.

Conditions

Healthy; ECG

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

FDA cleared ECG Holter

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CardiacSense Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fairview Health Services

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

CSF-3 ECG

Identifier Type: -

Identifier Source: org_study_id