Clincosm LogoSign in Get a demo

Evaluation of CSF-3 in Performing ECG

Sponsor
CardiacSense Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05591157
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
2.5
Anticipated Duration (Months)
15.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CSF-3 watch, designed to monitor a user's heart rate based on ECG (electrocardiogram) and PPG (Photoplethysmograph) readings
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Nov 16, 2022
Anticipated Primary Completion Date :
Dec 10, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. CSF-3 efficacy in ECG detection [6 months]

      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%.

    Secondary Outcome Measures

    1. CSF-3 HR calculation [6 months]

      Performance endpoint is defined as the calculation of average Heart Rate with ARMS error<3BPM

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fairview Health Services Minneapolis Minnesota United States 55102

    Sponsors and Collaborators

    • CardiacSense Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CardiacSense Ltd.
    ClinicalTrials.gov Identifier:
    NCT05591157
    Other Study ID Numbers:
    • CSF-3 ECG
    First Posted:
    Oct 24, 2022
    Last Update Posted:
    Dec 5, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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

    Study Results

    No Results Posted as of Dec 5, 2022