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

Study on the Compatibility of Twelve-lead Wearable Holter With MRI,CT,X-ray and Echocardiography

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07714109

Enrollment

500

Registered

2026-07-20

Start date

2025-12-18

Completion date

2026-08-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrhythmia

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Aged ≥18 years old; 2. Patients requiring MRI, CT, X-ray or cardiac ultrasound examination; 3. Voluntarily wear the 12-lead wearable ambulatory electrocardiography device during imaging examination; 4. Able to understand and sign the informed consent form independently.

Exclusion criteria

1. Severe skin damage, infection or allergy on chest skin unable to attach ECG electrodes; 2. Unstable critical condition, emergency rescue state; 3. Permanent magnet-containing implantable devices incompatible with magnetic resonance; 4. Mental disorders or cognitive dysfunction unable to cooperate with examination; 5. Pregnant women.

Design outcomes

Primary

Measure	Time frame	Description
Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations	Within 7 days after enrollment	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

Countries

China

Contacts

PRINCIPAL_INVESTIGATORBeibei Lin, MBBS

Second Affiliated Hospital, School of Medicine, Zhejiang University

Outcome results