Single-lead ECG patches plus heart sounds to measure heart intervals against standard ECG
Official title: Clinical Study on the Optimization Algorithm of Single-Lead Electrocardiogram Conduction Intervals
Run by Vivalink · NCT07667465 · Data updated 2026-11-12
Researchers test whether a wearable, single-lead ECG patch combined with synchronized heart sounds can accurately detect PR, QRS, and QT intervals compared with a traditional 12-lead ECG in adults.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Vivalink Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | July 16, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT07667465 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 or older with BMI under 35 kg/m², stable sinus rhythm, and at least one abnormal conduction interval.
✕Probably not a fit
Patients whose conduction intervals are not abnormal or whose anatomy prevents reliable patch recordings may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational study develops and validates an optimization algorithm that uses wearable ECG patches and synchronized heart sound data to measure conduction intervals. Adult participants with stable sinus rhythm and at least one abnormal conduction interval will undergo a brief session with ECG patches and a digital stethoscope, followed by a standard 12-lead ECG, and then a repeat patch/heart-sound session. The study trains and validates the algorithm by comparing its interval measurements to the clinical gold standard. Primary outcome focuses on the accuracy of the algorithm in identifying PR interval, QRS duration, and QT interval.
Why it matters
Potential benefit: If successful, the method could offer a convenient, noninvasive way to monitor key ECG intervals with wearable devices.
How similar studies have gone: Prior work has explored wearables for ECG intervals, with mixed success; this study extends approaches with synchronized heart sounds to improve accuracy.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.