[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646045":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":56,"collaborators":58,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":10,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":10,"enrollmentInfo":73,"targetDuration":10,"studyType":76,"phases":10,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":86,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Holter cohort",null,"Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period.",[13,14],"Device: 24-hour M2VS system multimodal vital sign monitoring","Other: Questionnaire regarding the usability and wearability",{"label":16,"type":10,"description":17,"interventionNames":18},"ABPM cohort","Participants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period.",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","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",[16,9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Questionnaire regarding the usability and wearability","Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.",[16,9],[30],{"name":31,"affiliation":5,"role":32},"Jens Eckstein, Prof. Dr.","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":10,"email":37},"CONTACT","+41 613287689","jens.eckstein@usb.ch",[39],{"facility":40,"status":10,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University Hospital Basel","Basel","Canton of Basel-City","4031","Switzerland","CH",{"type":47,"coordinates":48},"Point",[49,50],7.57327,47.55839,{"lat":50,"lon":49},[53],{"name":54,"role":35,"phone":55,"phoneExt":10,"email":37},"Prof. Dr. med. Jens Eckstein, PhD","0041-61-3287689",{"type":57,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[59,62],{"name":60,"class":61},"evismo AG","UNKNOWN",{"name":63,"class":6},"Bern University of Applied Sciences","100646045","feasibility-study-continuous-ecg-and-blood-pressure-monitoring-with-the-m2vs-sensor-system-100646045",false,"NCT07694570","Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System","Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.","Inclusion Criteria:\n\n* Written informed consent obtained prior to any project-specific procedures.\n* Age 18 years or older at the time of enrolment.\n* Ability to provide valid informed consent.\n* Clinical indication for 24-hour Holter monitoring (Holter cohort) or 24-hour ABPM (ABPM cohort).\n\nExclusion Criteria:\n\n* Insufficient knowledge of the German language, preventing adequate understanding of the project procedures and informed consent.\n* Enrolment of the project leader, project staff, their family members, employees, or other dependent persons.\n\nDermatological and Sensor Placement:\n\n* 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.\n* Excessive hair at the application site that could interfere with sensor coupling or signal quality.\n* Presence of other concurrent wearable devices at the same anatomical application site that could interfere with the M2VS system.\n* Known allergy to skin-contacting materials utilized in the M2VS system.","ALL","18 Years",{"count":74,"type":75},20,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.\n\nThe 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.\n\nIn the future, the results of this study may help make the monitoring of heart and blood vessel diseases more comfortable and easier for patients.",[79,80],"Atrial Fibrillation (Paroxysmal)","Hypertension",[82,83,84,85],"Feasibilty Study","M2VS system","ECG","Electrocardiogram","NOT_YET_RECRUITING","2026-07-03",{"date":89,"type":90},"2026-07-10","ACTUAL",{"date":92,"type":75},"2026-07-01",{"date":94,"type":75},"2026-08-31",{"name":5,"class":6},1]