Lessons from a multicenter clinical trial with an approved wearable electrocardiogram: issues and practical...

Area of Science:

• Biomedical Engineering
• Cardiology
• Clinical Trials

Background:

• Wearable electrocardiograms (ECGs) are increasingly used in clinical practice.
• Standardized validation methods for wearable ECGs are currently lacking.

Purpose of the Study:

• To perform an exploratory evaluation of a multicenter clinical trial using an approved wearable patch ECG.
• To assess the feasibility and data quality of wearable ECG implementation across different study centers.

Main Methods:

• A multicenter clinical trial involving 55 healthy male adults across 2 study centers.
• Deployment of approved wearable patch ECGs for 6 hours.
• Correlation analysis with conventional pulse oximetry and evaluation of data transmission status (valid, invalid, missing).

Main Results:

• Overall, 77.40% of heart rate data from wearable ECGs were valid.
• Significant differences in data validity and missingness were observed between the two centers.
• A poor correlation (ICC = 0.0454) was found between wearable ECG and pulse oximetry measurements.
• Missing data rates were 24.77% in center 1 versus 11.77% in center 2.

Conclusions:

• The study evaluated the multicenter feasibility of implementing wearable ECGs.
• Results indicate a need for systems to address multicenter discrepancies and artifact removal before clinical trials.
• Further development is required to standardize validation and ensure reliable data acquisition from wearable ECG devices.