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Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System
Sponsor: University Hospital, Basel, Switzerland
Summary
In this study, the investigators want to find out whether a new wearable sensor system, called the M2VS system, can reliably measure heart activity, blood pressure, and other vital signs over 24 hours during normal daily life. The investigators also want to compare the M2VS system with the standard devices currently used for long-term heart and blood pressure monitoring, such as a Holter ECG and an ambulatory blood pressure monitor (ABPM). This will provide an estimation of the accuracy of the M2VS system's ECG and blood pressure measurements compared to the standard devices. The aim of the study is to assess how reliable the M2VS system is in terms of data completeness and how comfortable it is to wear compared with the usual monitoring devices. In the future, the results of this study may help make the monitoring of heart and blood vessel diseases more comfortable and easier for patients.
Official title: Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
20
Start Date
2026-07-01
Completion Date
2026-08-31
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
24-hour M2VS system multimodal vital sign monitoring
The study features a dual-device monitoring approach integrated into the clinical routine: Participants receiving standard of care will concurrently wear the M2VS system for a 24-hour recording period.The M2VS system is designed for multimodal vital sign monitoring. It comprises a wearable and an associated belt system. The wearable consists of a battery pack and a recorder unit, that are connected via a sliding mechanism
Questionnaire regarding the usability and wearability
Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.
Locations (1)
University Hospital Basel
Basel, Canton of Basel-City, Switzerland