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Not Yet Recruiting NCT07694570

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

Conditions: Atrial Fibrillation (Paroxysmal), Hypertension

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 20
Sponsor: University Hospital, Basel, Switzerland

Location: University Hospital Basel Basel Canton of Basel-City

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07694570). StuddyBuddy aggregates publicly available trial information.