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

ConditionsAtrial Fibrillation (Paroxysmal)Hypertension
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • Questionnaire regarding the usability and wearability

    Other intervention

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Holter cohort2 interventions
Group B: ABPM cohort2 interventions

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

Similarity of ECG signal compared to Standard of Care

Agreement of the ECG signal between the investigational M2VS system and the standard of care reference devices. This evaluates the mean heart rate derived from ECG RR-intervals compared to the 24-hour Holter monitor. The overall similarity is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.

Time frame
24 hours
2

Similarity of Systolic Blood Pressure compared to Standard of Care

Agreement of systolic blood pressure between the investigational M2VS system and the standard of care reference devices. This evaluates the estimated systolic blood pressure derived from Pulse Arrival Time (using synchronous M2VS ECG and PPG signals) compared to the 24-hour Ambulatory Blood Pressure Monitor (ABPM). The overall similarity for these metrics is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.

Time frame
24 hours
3

Similarity of Diastolic Blood Pressure compared to Standard of Care

Agreement of diastolic blood pressure between the investigational M2VS system and the standard of care reference devices. This evaluates the estimated diastolic blood pressure derived from Pulse Arrival Time (using synchronous M2VS ECG and PPG signals) compared to the 24-hour Ambulatory Blood Pressure Monitor (ABPM). The overall similarity for these metrics is quantified using the Intraclass Correlation Coefficient. This is a Unitless index ranging from 0 to 1.

Time frame
24 hours
4

Reliability compared to Standard of Care

Quantification of the signal reliability and technical performance of the investigational M2VS system compared to the standard of care reference devices. This evaluates the technical data continuity and signal quality, measured as the percentage of the total recording period where the ECG and PPG data packets are continuous, gap-free, and meet acceptable Signal-to-Noise Ratio (SNR) and physiological thresholds to be considered usable.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

evismo AG

Collaborator

Bern University of Applied Sciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: