Targeted therapies such as osimertinib and alectinib, used to treat EGFR- and ALK-mutated non-small cell lung cancer (NSCLC), have substantially improved patient outcomes. However, both are known to cause cardiotoxic effects, including QTc prolongation and sinus bradycardia, which can lead to life-threatening arrhythmias.
Current clinical guidelines recommend regular electrocardiogram (ECG) monitoring for patients receiving tyrosine kinase inhibitors (TKIs). Yet, conventional 12-lead ECGs are impractical for frequent use in ambulatory oncology due to logistical, financial, and patient comfort barriers. The Corsano CardioWatch 287-2B, a medically regulated, wrist-worn wearable, provides a potential solution by enabling real-time, single-lead ECG monitoring in a patient-friendly format.
Study Objectives
This study aimed to evaluate the clinical accuracy, reproducibility, and diagnostic reliability of the Corsano CardioWatch’s ECG function in NSCLC patients undergoing TKI therapy.
Primary Outcome
• Reproducibility of ECG interval measurements (intra-device reliability)
Secondary Outcomes
• Agreement with conventional 12-lead ECGs
• Diagnostic performance for identifying abnormal rhythms
• Feasibility and patient tolerance in oncology practice
Study Design
As part of the prospective MOVIS-RESP trial, 71 NSCLC patients (39 on osimertinib, 32 on alectinib) underwent cardiac monitoring using both:
• Three consecutive Corsano CardioWatch 287-2B single-lead ECG recordings
• One 12-lead ECG performed in the outpatient clinic (gold standard)
Data were analyzed for signal quality, reproducibility, and concordance. Intraclass Correlation Coefficients (ICCs) were used to assess both reliability and agreement. ICC values range from 0 to 1, with values above 0.75 considered good and values above 0.90 considered excellent.
Inclusion Criteria
Adults with EGFR- or ALK-mutated NSCLC
Receiving osimertinib or alectinib treatment
Capable of seated ECG recording and informed consent
Exclusion Criteria
Inability to wear the Corsano device
Inability to undergo standard ECG testing
Results
A total of 213 Corsano ECG recordings were analyzed. Signal quality was high, with 96% of ECGs meeting analysis thresholds.
Intra-device reproducibility of ECG intervals using Corsano was:
• ‘Excellent’ for HR, RR, QTc (ICCs ≥ 0.91)
• ‘Good’ for QT and PR (ICCs 0.78–0.82)
• ‘Moderate’ for QRS duration (ICC 0.63)
Agreement with 12-lead ECGs was similarly strong:
• ‘Excellent’ for HR and QTc (ICCs ≥ 0.85)
• ‘Good’ for QT and RR (ICCs ~0.80)
• Lower for PR and QRS (ICCs ≤ 0.47), consistent with known limitations of single-lead ECGs
Diagnostic accuracy was high:
• Overall rhythm classification accuracy: 97%
• Kappa coefficient (κ) for inter-rater agreement:
• Sinus bradycardia: κ = 0.94
• Abnormal sinus rhythm: κ = 0.88
• All abnormal rhythms: κ = 0.93
These results demonstrate that the Corsano CardioWatch 287-2B reliably captures the key ECG parameters relevant to TKI safety monitoring, with rapid, reproducible, and accurate results suitable for ambulatory settings.
Timeline
Status: Completed – Publication pending
Study Period: November 2024 – June 2025
Study center
Erasmus Medical Center (EMC), Rotterdam, The Netherlands
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!
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.
