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Single-Lead ECG Conduction Interval Algorithm

NCT07667465 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-07-21

No results posted yet for this study

Summary

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.

Conditions

  • Conduction of Electrocardiogram

Sponsors & Collaborators

  • Second Affiliated Hospital, Zhejiang University, School of Medicine

    collaborator OTHER

  • Vivalink

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-16
Primary Completion
2027-02-28
Completion
2027-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667465 on ClinicalTrials.gov