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NCT07667465

Clinical Study on the Optimization Algorithm of Single Lead Electrocardiogram Conduction Interval

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

Summary

The goal of this observational study is to develop and validate an optimization algorithm for single-lead ECG conduction intervals using a wearable ECG patch combined with synchronized heart sound data, and to evaluate its agreement with the clinical gold standard (12-lead ECG) in adult patients. The main question it aims to answer is: Does the optimized algorithm, based on ECG patch and synchronous heart sound recordings, improve the detection accuracy of PR interval, QRS duration, and QT interval compared to standard 12-lead ECG? Participants (age ≥18 years, BMI \<35 kg/m², stable sinus rhythm with at least one abnormal conduction interval) will undergo two 2-minute sessions of simultaneous ECG patch and digital stethoscope recordings, followed by standard 12-lead ECG. Data will be used for algorithm training and validation, with primary endpoints being the sensitivity and specificity of the optimized intervals against the gold standard.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-06-01

Completion Date

2027-05-31

Last Updated

2026-06-25

Healthy Volunteers

Not specified