Twelve-lead Wearable Holter,MRI,CT,X-ray,Echocardiography

NCT07714109 | Active Not Recruiting

• 1 other identifier: 研2025-1209
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The 12-lead wearable Holter monitor is compatible with most examinations including MRI, CT, X-ray and echocardiography without compromising data quality. It helps shorten patients' medical visit duration and improves the detection rate of arrhythmias.

Conditions

Cardiac Arrhythmia

Keywords

12-lead wearable Holter,arrhythmia,dynamic electrocardiogram,wearable ECG,cardiac monitoring

Outcome Measures

Primary Outcomes (1)

• Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations

  The proportion of participants with no equipment failure,severe ECG signal interference and related adverse reactions when wearing the 12-lead wearable Holter to receive MRI,CT,X-ray and echocardiography examinations

  Within 7 days after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 to 99 years old who need to receive MRI, CT, X-ray or echocardiography examinations, and are willing to wear 12-lead wearable ambulatory electrocardiography and sign informed consent.

You may qualify if:

• Aged ≥18 years old;
• Patients requiring MRI, CT, X-ray or cardiac ultrasound examination;
• Voluntarily wear the 12-lead wearable ambulatory electrocardiography device during imaging examination;
• Able to understand and sign the informed consent form independently.

You may not qualify if:

• Severe skin damage, infection or allergy on chest skin unable to attach ECG electrodes;
• Unstable critical condition, emergency rescue state;
• Permanent magnet-containing implantable devices incompatible with magnetic resonance;
• Mental disorders or cognitive dysfunction unable to cooperate with examination;
• Pregnant women.

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Beibei Lin, MBBS

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: December 18, 2025
• Primary Completion: June 12, 2026
• Study Completion: August 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)