Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)

NCT07684807 | Not Yet Recruiting

• 1 other identifier: ILECS-ECGPPG
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Electrocardiography (ECG); Photoplethysmography; Healthy Volunteers

Keywords

ECG; PPG; Wearable device; CardioWatch; Digital Health

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (1)

• Usability/comfort of Corsano CardioWatch 287-2 (questionnaire) and technical issue rates (e.g., sensor detachment, connectivity interruptions)

  24 hours

Study Arms (1)

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

Device: Corsano CardioWatch 287-2; Device: VivaLNK wearable ECG patch

Interventions

Corsano CardioWatch 287-2 DEVICE

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.

Healthy adult volunteers

VivaLNK wearable ECG patch DEVICE

Continuous reference ECG device used as the gold standard for synchronized ECG recordings and QT/QTc reference annotation

Healthy adult volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers, including hospital employees, recruited at a single clinical site.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corsano Health B.V.: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06