Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05591157
Status:
COMPLETED
Last Update Posted:
2023-02-10
First Post:
2022-10-19
Brief Title:
Evaluation of CSF-3 in Performing ECG
Sponsor:
CardiacSense Ltd
Organization:
CardiacSense Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECG
Brief Summary:
CSF-3 is a wrist-worn medical device similar to a watch It is designed to monitor a users 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 hearts 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 studys 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
Subjects will be screened by the Principal Investigator Subjects who meet the studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None