Single-Lead ECG Conduction Interval Algorithm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Conduction of Electrocardiogram. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Study on the Optimization Algorithm of Single-Lead Electrocardiogram Conduction Intervals
Overview
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.
Primary outcome measures
- PR interval [Time frame: 10-15 minutes]
- QRS duration [Time frame: 10-15 minutes]
- QT interval [Time frame: 10-15 minutes]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT07667465 · 20260674