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Evaluation of Remote Programming Safety and Efficacy Under Multidisciplinary Collaboration for MRI in CIED Patients: A Multicenter Clinical Trial

Evaluation of Remote Programming Safety and Efficacy Under Multidisciplinary Collaboration for MRI in CIED Patients: A Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108263
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-08-28
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

Sick Sinus Syndrome( SSS)

Interventions

Single-arm study:CIED remote programming

Sponsors

The Third People's Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Aged >= 18 years, with no restriction on gender. 2.The implanted CIEDs are MR-compatible devices; (CIEDs in this study include cardiac pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy-defibrillators (CRT-Ds)). 3.The electrode position has been stable in the 5 weeks prior to the study. 4.CIED parameters are normal: pacing threshold 30%; no phrenic nerve stimulation at 4.8 V@1.0 ms. 5.Voluntarily participate in this clinical study, be able to complete the follow-up required by the study, and have signed a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Non-MR-compatible implanted devices (pulse generators, electrodes); 2.Presence of any of the following conditions: electrode damage, electrode extenders, adapters, or abandoned electrodes; if necessary, a chest X-ray can be completed before the examination. 3.Having other contraindications to MRI examination.

Design outcomes

Primary

MeasureTime frame
Remote programming completion rate;Incidence rate of adverse events related to remote programming;

Secondary

MeasureTime frame
Incidence rate of MRI examination-related adverse events;Incidence rate of adverse events;

Countries

China

Contacts

Public ContactHanxiong Liu

The Third People's Hospital of Chengdu

lhanx@126.com+86 28 6131 8656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026