Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System

NCT07694570 · tracked via the Priya Life Science Switzerland tracker

Sponsor

University Hospital, Basel, Switzerland

Phase

Observational

Started

2026-07-01

Last updated

2026-07-10

Condition(s) studied

Atrial Fibrillation (Paroxysmal)Hypertension

Investigational drug(s) / intervention(s)

24-hour M2VS system multimodal vital sign monitoringQuestionnaire regarding the usability and wearability

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Written informed consent obtained prior to any project-specific procedures. * Age 18 years or older at the time of enrolment. * Ability to provide valid informed consent. * Clinical indication for 24-hour Holter monitoring (Holter cohort) or 24-hour ABPM (ABPM cohort). Exclusion Criteria: * Insufficient knowledge of the German language, preventing adequate understanding of the project procedures and informed consent. * Enrolment of the project leader, project staff, their family members, employees, or other dependent persons. Dermatological and Sensor Placement: * Pre-existing skin conditions at the application sites (medial upper arm or chest), such as extensive scarring, tattoos, open wounds, active inflammation, or severe oedema that could interfere with sensor coupling or signal quality. * Excessive hair at the application site that could interfere with sensor coupling or signal quality. * Presence of other concurrent wearable devices at the same anatomical application site that could interfere with the M2VS system. * Known allergy to skin-contacting materials utilized in the M2VS system.

Primary outcome measure(s)

Strong signal-to-noise ratio — 24 hours
A strong signal-to-noise ratio (dB), ensuring signals received lie within a range that is physiologically feasible and are usable for further vital sign analysis, and the percentage of continuous, gap-free recording time.

Trial sites (1)

Facility	City	Region	Status
University Hospital Basel	Basel	Canton of Basel-City

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07694570 on ClinicalTrials.gov ↗ ← All trials in Switzerland