Evaluation of CSF-3 in Performing ECG

Completed · Not applicable

Conditions studied: Healthy, ECG

In brief

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.

Key facts

Study ID

NCT05591157

Run by

CardiacSense Ltd.

People needed

47

Starts

2022-11-16

Expected to finish

2023-02-01

Last updated by the study team

2023-02-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Fairview Health Services — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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