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NCT07667465
Single-Lead ECG Conduction Interval Algorithm
Conditions: Conduction of Electrocardiogram
Sex: All
Ages: 18 Years – N/A
Enrollment: 50
Sponsor: Vivalink
Location: Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang
Summary
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: 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? It aims to answer: Participants (age ≥18 years, BMI \
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.
Source: ClinicalTrials.gov (NCT07667465). StuddyBuddy aggregates publicly available trial information.