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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Conduction of Electrocardiogram

• Study Type: Observational
• Enrollment (Estimated): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The subjects were selected from those who were aged 18 years or above, had a body mass index of less than 35 kg/m2, had stable sinus rhythm; and whose PR interval, QRS duration or QT interval were stable but at least one of them was outside the normal range. They also had a full understanding of the trial purpose and process and voluntarily signed the informed consent form.

Description

Inclusion Criteria:

• Age ≥18 years;
• body mass index < 35 kg/m2;
• with stable sinus rhythm;
• PR interval, QRS duration, or QT interval were stable and at least one was outside the normal range;
• fully understood the purpose and procedure of the trial and voluntarily signed an informed consent form.

Exclusion Criteria:

• There are physical disabilities that prevent safe and thorough testing;
• Open wounds on the chest skin or skin allergy to patches;
• Post-implantation of temporary or permanent cardiac pacemaker, ICD, CRT or CRTD, after artificial heart valve replacement, with large amounts of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, large amounts of pleural effusion, etc., which may affect data collection;
• The patient has severe comorbidities or unstable condition, which may interfere with data collection during the study period;
• Other situations where the researcher considers the subject unsuitable to participate in this trial, such as potentially increasing the risk of the trial, affecting the subject's compliance with the protocol, or affecting the subject's ability to complete the trial due to physical or psychological diseases or conditions.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
PR intervals	About half an hour.
QRS duration	About half an hour.
QT interval	About half an hour.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20260674