Health Trials

Single-Lead ECG Conduction Interval Algorithm

ConditionConduction of Electrocardiogram
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVivalink

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Sponsors and collaborators

Vivalink

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborator

Source ClinicalTrials.gov