Single-Lead ECG Conduction Interval Algorithm

Clinical Study on the Optimization Algorithm of Single-Lead Electrocardiogram Conduction Intervals

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

Study Overview

• Status: Recruiting
• Conditions: Conduction of Electrocardiogram

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

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Principal Investigator: Xiaojie Xie
      • Contact: Bing Yang; Phone Number: +86 13395719536; Email: yangbing@vivalink.com.cn

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with stable sinus rhythm, at least one stable and abnormal conduction interval (PR, QRS, or QT)

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;
• Able to fully understand the purpose and process of the trial, and willing to sign the informed consent form.

Exclusion Criteria:

• Physical disabilities that prevent safe and thorough testing;
• Open wounds on the chest or skin is allergy to patches;
• Post-implantation of temporary or permanent cardiac pacemaker, ICD, CRT or CRTD, post-replacement of artificial heart valve, with large amounts of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, large amounts of pleural effusion, etc., which may affect data collection;
• Patients with severe comorbidities or unstable condition, which may interfere with data collection during the study period;
• Other situations where the investigator believes the subject is not suitable to participate in this trial, such as those that may increase trial risk, affect the protocol compliance, or impair 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 interval	10-15 minutes
QRS duration	10-15 minutes
QT interval	10-15 minutes

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 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): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 20260674