Single-Lead ECG Conduction Interval Algorithm

NCT07667465 | Recruiting

• 1 other identifier: 20260674
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• PR interval

  10-15 minutes

• QRS duration

  10-15 minutes

• QT interval

  10-15 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with stable sinus rhythm, at least one stable and abnormal conduction interval (PR, QRS, or QT)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vivalink: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 25, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

CN (1)