Atrial Fibrillation (Paroxysmal)NCT07694570
Feasibility Study: Continuous ECG and Blood Pressure Monitoring With the M2VS Sensor System
An observational study of Atrial Fibrillation (Paroxysmal) and Hypertension, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal), Hypertension
- What is being tested?
- 24-hour M2VS system multimodal vital sign monitoring and Questionnaire regarding the usability and wearability
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2026to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
Prof. Dr. med. Jens Eckstein, PhD, 0041-61-3287689, jens.eckstein@usb.ch
About this study
Official title: Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.
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.
Read more
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.
Read the detailed description
Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Long-term ambulatory monitoring of electrocardiography (ECG) and blood pressure is essential for the detection and management of conditions such as paroxysmal atrial fibrillation and masked hypertension. However, current standard monitoring devices, including Holter ECG monitors and ambulatory blood pressure monitors, may be limited by reduced wearing comfort, skin irritation from adhesive electrodes, motion artefacts, and discontinuous blood pressure measurements.
This feasibility study evaluates a novel wearable sensor system, the M2VS system, designed as a flexible textile-based band integrating dry electrodes and multiple sensors for continuous multimodal vital signs monitoring. The system records ECG, photoplethysmography (PPG), inertial measurement unit (IMU) data, body temperature, bioimpedance, acoustic respiratory signals, and piezo sensor data over a 24-hour period in daily life. In this study, the M2VS system will be used strictly as a non-diagnostic data logger.
This study will provide critical insights into the signal quality and technical reliability of a non-invasive, multi-sensor wearable compared to current standard of care (Holter monitor and ABPM). By evaluating the wearable, the research aims to overcome the comfort and compliance barriers of existing monitoring systems. These findings may represent a significant step toward developing more reliable, continuous diagnostic tools for the long-term management of conditions like atrial fibrillation and hypertension.
- Conditions
- Atrial Fibrillation (Paroxysmal), Hypertension
- Being tested
- 24-hour M2VS system multimodal vital sign monitoring, Questionnaire regarding the usability and wearability
- Keywords
- Feasibilty Study, M2VS system, ECG, Electrocardiogram
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour M2VS system multimodal vital sign monitoringDevice
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 wearabilityOther
Questionnaire regarding the usability and wearability of both the M2VS system and the standard of care device.
| Study group | Role | What they receive |
|---|---|---|
| Holter cohort | Participants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period. Receives: 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. Receives: Device: 24-hour M2VS system multimodal vital sign monitoring; Other: Questionnaire regarding the usability and wearability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (7)
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
Wearability of M2VS
Participant-reported wearability of the M2VS system compared to standard of care devices, assessed via a structured questionnaire administered upon device removal. Responses are measured on a Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores from reverse-coded items will be inverted before the mean score is calculated. A higher mean score indicates better usability and wearability.
Measured: After the 24-hour monitoring period
Localization of Physical Discomfort
Participant-reported areas of discomfort marked on a body map and supplemented by qualitative notes on the corresponding area.
Measured: 24 hours (Upon device removal)
Acceptance compared to Standard of Care
Participant acceptance of the M2VS device compared to standard of care devices, assessed via the Net Promoter Score (NPS). The NPS is calculated using a single question ("How likely are you to recommend...?") on a scale from 0 (not at all likely) to 10 (extremely likely). The final NPS ranges from 0 to 10, where a higher score indicates a higher level of participant acceptance.
Measured: 24 hours (Upon device removal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- evismo AG, Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Jens Eckstein, Prof. Dr., Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694570
- Sponsor's protocol ID
- 2026-01087; am25eckstein2
- Status last verified
- Jul 2026
- First submitted
- 25 Jun 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for Continuous Monitoring of Electrocardiogram (ECG) and Blood Pressure at the Chest and Upper Arm Using the M2VS System.
- ClinicalTrials.gov ID
- NCT07694570
- Acronym / sponsor ID
- 2026-01087; am25eckstein2
- Conditions
- Atrial Fibrillation (Paroxysmal), Hypertension
- Keywords
- Feasibilty Study, M2VS system, ECG, Electrocardiogram
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- evismo AG, Bern University of Applied Sciences
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular diseases remain a leading cause of morbidity and mortality worldwide. Long-term ambulatory monitoring of electrocardiography (ECG) and blood pressure is essential for the detection and management of conditions such as paroxysmal atrial fibrillation and masked hypertension. However, current standard monitoring devices, including Holter ECG monitors and ambulatory blood pressure monitors, may be limited by reduced wearing comfort, skin irritation from adhesive electrodes, motion artefacts, and discontinuous blood pressure measurements.
This feasibility study evaluates a novel wearable sensor system, the M2VS system, designed as a flexible textile-based band integrating dry electrodes and multiple sensors for continuous multimodal vital signs monitoring. The system records ECG, photoplethysmography (PPG), inertial measurement unit (IMU) data, body temperature, bioimpedance, acoustic respiratory signals, and piezo sensor data over a 24-hour period in daily life. In this study, the M2VS system will be used strictly as a non-diagnostic data logger.
This study will provide critical insights into the signal quality and technical reliability of a non-invasive, multi-sensor wearable compared to current standard of care (Holter monitor and ABPM). By evaluating the wearable, the research aims to overcome the comfort and compliance barriers of existing monitoring systems. These findings may represent a significant step toward developing more reliable, continuous diagnostic tools for the long-term management of conditions like atrial fibrillation and hypertension.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holter cohort | – | Device: 24-hour M2VS system multimodal vital sign monitoring, Other: Questionnaire regarding the usability and wearabilityParticipants receiving standard of care Holter monitoring will concurrently wear the M2VS system for a 24-hour recording period. |
| ABPM cohort | – | Device: 24-hour M2VS system multimodal vital sign monitoring, Other: Questionnaire regarding the usability and wearabilityParticipants undergoing standard-of-care ABPM will concurrently wear the M2VS system during the same 24-hour monitoring period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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.
- Presence of other concurrent wearable devices at the same anatomical application site that could interfere with the M2VS system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour M2VS system multimodal vital sign monitoringThe 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 | Device | ABPM cohort, Holter cohort |
| Questionnaire regarding the usability and wearabilityQuestionnaire regarding the usability and wearability of both the M2VS system and the standard of care device. | Other | ABPM cohort, Holter cohort |
Primary outcome
Strong signal-to-noise ratio
Time frame: 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.
7 secondary outcomes
Similarity of ECG signal compared to Standard of Care
Time frame: 24 hours
Similarity of Systolic Blood Pressure compared to Standard of Care
Time frame: 24 hours
Similarity of Diastolic Blood Pressure compared to Standard of Care
Time frame: 24 hours
Reliability compared to Standard of Care
Time frame: 24 hours
Wearability of M2VS
Time frame: After the 24-hour monitoring period
Localization of Physical Discomfort
Time frame: 24 hours (Upon device removal)
Acceptance compared to Standard of Care
Time frame: 24 hours (Upon device removal)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jens Eckstein, Prof. Dr. principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (Paroxysmal) and Hypertension, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jens Eckstein, Prof. Dr. (+41 613287689, jens.eckstein@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strong signal-to-noise ratio (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.