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NCT07684807
Synchronised ECG and PPG Data Collection for AI-based QT/QTc Reconstruction (ILECS-ECGPPG)
Conditions: Electrocardiography (ECG), Photoplethysmography, Healthy Volunteers
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 50
Sponsor: Corsano Health B.V.
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 \23 cm.
* Any participant who, in the investigator's opinion, does not meet study requirements
Source: ClinicalTrials.gov (NCT07684807). StuddyBuddy aggregates publicly available trial information.