Electrocardiography (ECG)ILECS-ECGPPGNCT07684807
Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)
An observational study of Electrocardiography (ECG) and Photoplethysmography, run by Corsano Health B.V..
Trial summary
This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers. Participants will wear the Corsano CardioWatch 297-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Electrocardiography (ECG), Photoplethysmography, Healthy Volunteers
- What is being tested?
- Corsano CardioWatch 287-2 and VivaLNK wearable ECG patch
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers, including hospital employees, recruited at a single clinical site.
Who may be able to join
- Able to provide written informed consent.
- Willing and able to comply with all study procedures and attend the required study visits.
- Age ≥18 years.
- Able to read or understand Dutch or English.
Who cannot join
- Children/minors or vulnerable individuals.
- Skin conditions or allergies preventing safe wear of the CardioWatch or ECG electrodes.
- Any condition that, in the investigator's opinion, may interfere with study completion or data quality.
- Compromised circulation, injury, or physical malformation at sensor sites.
- Known clotting disorders or current prescription anticoagulant therapy.
- Other health conditions preventing safe participation.
- Wrist circumference <14 cm or >23 cm.
- Any participant who, in the investigator's opinion, does not meet study requirements
About this study
Official title: Collection of Synchronised ECG and PPG Recordings in Healthy Adult Volunteers to Develop and Evaluate AI Methods for ECG- Parameter Reconstruction From PPG (Focus: QT/QTc).
This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers. Participants will wear the Corsano CardioWatch 297-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-lining conditions. The objective is to generate a high-quality paired ECG-PPG dataset to support the development and evaluation of artificial intelligence methods fro reconstructing ECG parameters, with a particular focus on QT/QTc, from PPG signals. The study will also evaluate the feasibility and usability of the wearable monitoring system.
Read the detailed description
Wearable devices have the potential to support continuous physiological monitoring in both clinical and home settings. Although photoplethysmography (PPG) enables comfortable long-term monitoring, it does not directly provide electrocardiographic (ECG) information. This study aims to establish a synchronized dataset of ECG and PPG recordings that can be used to develop and evaluate artificial intelligence algorithms for reconstructing ECG parameters, particularly QT/QTc, from PPG signals.
Approximately 50 healthy adult volunteers will be enrolled in this single-center, single-arm observational feasibility study. Participants will wear the Corsano CardioWatch 287-2 together with a reference continuous ECG device for approximately 24 hours. During the study, synchronized recordings will be collected during standardized activities (rest, standing, and light walking) as well as during normal daily activities.
The primary endpoints include completeness of paired ECG-PPG recordings, synchronization quality, and the proportion of recordings suitable for QT/QTc annotation. Secondary endpoints include participant comfort and usability of the wearable monitoring system, together with technical performance measures such as signal quality, device connectivity, and data completeness.
The resulting dataset will support future development and validation of AI-based methods for ECG parameter reconstruction from wearable PPG signals.
- Being tested
- Corsano CardioWatch 287-2, VivaLNK wearable ECG patch
- Keywords
- ECG, PPG, Wearable device, CardioWatch, Digital Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corsano CardioWatch 287-2Device
Wrist-worn wearable device used to collect continuous photoplethysmography (PPG) signals and related physiological data during the study. The device is used simultaneously with a reference ECG device to generate synchronized ECG-PPG datasets for AI algorithm development and evaluation.
VivaLNK wearable ECG patchDevice
Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation
| Study group | Role | What they receive |
|---|---|---|
| Healthy adult volunteers | Approximately 50 healthy adult volunteers who will wear the Corsano CardioWatch 287-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-living monitoring, to collect synchronized ECG and PPG recordings Receives: Device: Corsano CardioWatch 287-2; Device: VivaLNK wearable ECG patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation
Assessment of paired ECG-PPG recording completeness, synchronization quality using offset and drift indicators, and the proportion of usable segments for QT/QTc reference annotation
Measured: 24 hours
Secondary outcomes (1)
Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)
Assessment of participant-reported usability and comfort of the Corsano CardioWatch 287-2 using a questionnaire, together with the frequency and type of technical issues affecting data collection, including sensor detachment, connectivity interruptions, and other technical problems encountered during the study
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrocardiography (ECG)Studies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corsano Health B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684807
- Sponsor's protocol ID
- ILECS-ECGPPG
- Acronym
- ILECS-ECGPPG
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Synchronised ECG and PPG Recordings in Healthy Adult Volunteers to Develop and Evaluate AI Methods for ECG- Parameter Reconstruction From PPG (Focus: QT/QTc).
- ClinicalTrials.gov ID
- NCT07684807
- Acronym / sponsor ID
- ILECS-ECGPPG / ILECS-ECGPPG
- Keywords
- ECG, PPG, Wearable device, CardioWatch, Digital Health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Corsano Health B.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 6 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.
This observational study will collect synchronized photoplethysmography (PPG) and electrocardiogram (ECG) recordings from approximately 50 healthy adult volunteers. Participants will wear the Corsano CardioWatch 297-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-lining conditions. The objective is to generate a high-quality paired ECG-PPG dataset to support the development and evaluation of artificial intelligence methods fro reconstructing ECG parameters, with a particular focus on QT/QTc, from PPG signals. The study will also evaluate the feasibility and usability of the wearable monitoring system.
Detailed description
Wearable devices have the potential to support continuous physiological monitoring in both clinical and home settings. Although photoplethysmography (PPG) enables comfortable long-term monitoring, it does not directly provide electrocardiographic (ECG) information. This study aims to establish a synchronized dataset of ECG and PPG recordings that can be used to develop and evaluate artificial intelligence algorithms for reconstructing ECG parameters, particularly QT/QTc, from PPG signals.
Approximately 50 healthy adult volunteers will be enrolled in this single-center, single-arm observational feasibility study. Participants will wear the Corsano CardioWatch 287-2 together with a reference continuous ECG device for approximately 24 hours. During the study, synchronized recordings will be collected during standardized activities (rest, standing, and light walking) as well as during normal daily activities.
The primary endpoints include completeness of paired ECG-PPG recordings, synchronization quality, and the proportion of recordings suitable for QT/QTc annotation. Secondary endpoints include participant comfort and usability of the wearable monitoring system, together with technical performance measures such as signal quality, device connectivity, and data completeness.
The resulting dataset will support future development and validation of AI-based methods for ECG parameter reconstruction from wearable PPG signals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adult volunteers | – | Device: Corsano CardioWatch 287-2, Device: VivaLNK wearable ECG patchApproximately 50 healthy adult volunteers who will wear the Corsano CardioWatch 287-2 and a reference ECG device simultaneously for approximately 24 hours, including standardized activities and free-living monitoring, to collect synchronized ECG and PPG recordings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers, including hospital employees, recruited at a single clinical site.
Key inclusion criteria (4 listed)
- Able to provide written informed consent.
- Willing and able to comply with all study procedures and attend the required study visits.
- Age ≥18 years.
- Able to read or understand Dutch or English.
Key exclusion criteria (8 listed)
- Children/minors or vulnerable individuals.
- Skin conditions or allergies preventing safe wear of the CardioWatch or ECG electrodes.
- Any condition that, in the investigator's opinion, may interfere with study completion or data quality.
- Compromised circulation, injury, or physical malformation at sensor sites.
- Known clotting disorders or current prescription anticoagulant therapy.
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 |
|---|---|---|
| Corsano CardioWatch 287-2Wrist-worn wearable device used to collect continuous photoplethysmography (PPG) signals and related physiological data during the study. The device is used simultaneously with a reference ECG device to generate synchronized ECG-PPG datasets for AI algorithm development and evaluation. | Device | Healthy adult volunteers |
| VivaLNK wearable ECG patchContinuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation | Device | Healthy adult volunteers |
Primary outcome
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation
Time frame: 24 hours
Assessment of paired ECG-PPG recording completeness, synchronization quality using offset and drift indicators, and the proportion of usable segments for QT/QTc reference annotation
1 secondary outcome
Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)
Time frame: 24 hours
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 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Electrocardiography (ECG) and Photoplethysmography, run by Corsano Health B.V..
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 8 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 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness of paired recordings, synchronisation quality (offset/drift indicators), and proportion of usable segments for QT/QTc reference annotation (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 6 Jul 2026.