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

NCT07694570 | Not Yet Recruiting

• 1 other identifier: 2026-01087; am25eckstein2
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (Paroxysmal); Hypertension

Keywords

Feasibilty Study; M2VS system; ECG; Electrocardiogram

Outcome Measures

Primary Outcomes (1)

• Strong signal-to-noise ratio

  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.

  24 hours

Secondary Outcomes (7)

• Similarity of ECG signal compared to Standard of Care

  24 hours

• Similarity of Systolic Blood Pressure compared to Standard of Care

  24 hours

• Similarity of Diastolic Blood Pressure compared to Standard of Care

  24 hours

• Reliability compared to Standard of Care

  24 hours

• Wearability of M2VS

  After the 24-hour monitoring period

Study Arms (2)

Holter cohort

Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.

Device: 24-hour M2VS system multimodal vital sign monitoring; Other: Questionnaire regarding the usability and wearability

ABPM cohort

Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.

Device: 24-hour M2VS system multimodal vital sign monitoring; Other: Questionnaire regarding the usability and wearability

Interventions

24-hour M2VS system multimodal vital sign monitoring DEVICE

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

ABPM cohort; Holter cohort

Questionnaire regarding the usability and wearability OTHER

Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.

ABPM cohort; Holter cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The project population consists of adult participants (≥18 years) recruited at the USB who have a clinical indication for either 24-hour Holter monitoring or 24-hour ABPM. A total of N=20 participants will be enrolled, N=10 for the Holter cohort and N=10 for the ABPM cohort.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• evismo AG: collaborator
• Bern University of Applied Sciences: collaborator

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Hypertension

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Officials

• Jens Eckstein, Prof. Dr.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jens Eckstein, Prof. Dr.

CONTACT

+41 613287689; jens.eckstein@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)