Validation of Corsano CardioWatch 287-2B for Heart Rate Monitoring in Children

Rationale
Reliable heart rate (HR) monitoring in children is essential for both diagnostic and therapeutic monitoring in pediatric cardiology. Traditional 24-hour Holter ECGs remain the clinical gold standard but are often perceived as bulky, uncomfortable, and limited in-patient usability, particularly in children.

The Corsano CardioWatch 287-2B offers a promising alternative: a lightweight, wrist-worn wearable device capable of continuous, non-invasive monitoring. Its potential to replace or complement Holter ECGs could improve patient comfort, extend monitoring periods, and support earlier identification of arrhythmias or other cardiovascular conditions in pediatric populations.

Study Objectives
This study assessed the accuracy, agreement, and user satisfaction of heart rate measurements recorded by the Corsano CardioWatch 287-2B, using 24-hour Holter ECG as the reference standard.

Primary Outcome
• Proportion of Corsano heart rate readings within 10% of Holter ECG values
Secondary Outcomes
• Agreement analysis via Bland-Altman methods
• Subgroup performance based on activity level, heart rate range, and body composition
• User satisfaction in comparison to Holter ECG

Study Design
In this prospective, single-center validation study, children scheduled for 24-hour Holter monitoring at Erasmus MC’s pediatric cardiology outpatient clinic were simultaneously equipped with the Corsano CardioWatch 287-2B. All measurements were collected over the same period, with data from the wearable compared directly against the Holter ECG. Participant feedback was collected via a standardized Likert-scale questionnaire to assess comfort, ease of use, and overall satisfaction.

Inclusion Criteria
• Children referred for 24-hour Holter ECG monitoring
• Ability to wear the study devices
• Parental consent and child assent obtained

Exclusion Criteria
• Dermatological issues or anatomical constraints preventing wearable use
• Lack of consent

Current Status
The study has been completed with 31 pediatric participants (mean age 13.2 ± 3.6 years; 45% female) evaluated using the Corsano CardioWatch 287-2B.
Key findings include:
• Mean HR accuracy: 84.8% (¬±8.7%) within 10% of Holter ECG values
• Higher accuracy at lower heart rates: 90.9% vs. 79.0% at elevated HRs (p<.001)
• Bland-Altman agreement: Mean bias -1.4 BPM; 95% limits of agreement -18.8 to 16.0 BPM
• Patient satisfaction: Corsano scored significantly higher (median 3.8/5) than Holter ECG (2.6/5)
• These results confirm that the Corsano CardioWatch 287-2B delivers clinically relevant accuracy with superior comfort, suggesting it may serve as a viable, child-friendly alternative to standard ECG monitoring in pediatric care.

Timeline
Status: Completed
Study Period: 2024–2025

Study center
Erasmus Medical Center (EMC), Rotterdam, The Netherlands

Publication
Preprint Available: JMIR Preprints (2025)

Interested in our Trial Programme?

Corsano Cardiowatch Bracelets enable continuous monitoring with multiple algorithms. Corsano is working closely with cardiologists, scientists, hospitals, patients, and research organisations.  Scientific research demonstrates the legitimacy of Cardiowatch 287 algorithms. 

We are currently performing pilots with selected clients. Contact us if you want to know more!

Corsano CardioWatch is a wrist worn medical grade multi sensor bracelet to capture up to 19 vital parameters. Primary use cases are 24/7 continuous clinical trials and remote patient monitoring.  
 
The bracelet monitor offers flexibility to set data collection intervals by minute, by second or 25Hz, 32 Hz or 128 Hz. We measure Heart Rate, RR intervals, Breathing Rate, A-Fib detection, Skin Temperature, Activity and Sleep. SpO2, Core Body Temperature, ECG and Blood Pressure are in development.  
 
Clinical accuracy is paramount for us. In addition to third parties' algorithms, i.e. from Philips, we run our proprietary algorithms to realize superior data accuracy. Corsano technology has been clinically validated in major academic hospitals. The bracelet is manufactured under ISO 13485 and CE-MDR compliance. The process for FDA Clearance has started. 
 
Our end-to-end solution consists of light-weight and comfortable bracelets with a patient research portal. We have developed and produced over 200’000 devices. The Corsano platform has been optimized on connections, data buffers and battery life up to 15 days. We offer access to raw continuous high frequency data through API and cloud-to-cloud solutions. 
 

The founders of Corsano Health have over 100 years of experience in the Swiss Watch industry, with deep experience about ergonomic design and materials for wearables that are worn 24/7.