Evaluation of CSF-3 in Performing ECG

NCT05591157 | Completed FDA Device

• 1 other identifier: CSF-3 ECG
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; ECG

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• CSF-3 HR calculation

  6 months

Study Arms (1)

CSF-3 and ECG Holter

EXPERIMENTAL

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

Interventions

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

Also known as: FDA cleared ECG Holter

CSF-3 and ECG Holter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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

Sponsors & Collaborators

• CardiacSense Ltd.: lead

Study Sites (1)

Fairview Health Services

Minneapolis, Minnesota, 55102, United States

Location

MeSH Terms

Interventions

Electrocardiography

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 24, 2022
• Study Start: November 16, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)