Cardiac ArrhythmiaNCT07714109
Twelve-lead Wearable Holter,MRI,CT,X-ray,Echocardiography
An observational study of Cardiac Arrhythmia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 18 Dec 2025to Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
About this study
Official title: Study on the Compatibility of Twelve-lead Wearable Holter With MRI,CT,X-ray and Echocardiography
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
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start18 Dec 2025
- Primary completion12 Jun 2026
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beibei Lin, MBBS, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714109
- Sponsor's protocol ID
- 研2025-1209
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participants' privacy and confidential clinical information. Only aggregate statistical results will be published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Compatibility of Twelve-lead Wearable Holter With MRI,CT,X-ray and Echocardiography
- ClinicalTrials.gov ID
- NCT07714109
- Acronym / sponsor ID
- 研2025-1209
- Conditions
- Cardiac Arrhythmia
- Keywords
- 12-lead wearable Holter,arrhythmia,dynamic electrocardiogram,wearable ECG,cardiac monitoring
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participants' privacy and confidential clinical information. Only aggregate statistical results will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beibei Lin, MBBS principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance qualification rate of 12-lead wearable ambulatory electrocardiography with routine imaging examinations (time frame: Within 7 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.