Registry Study of Clinical Application of MRI Compatible CIED
Completed
- Conditions
- Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
- Registration Number
- NCT02380300
- Lead Sponsor
- Biotronik (Beijing) Medical Device Ltd.
- Brief Summary
The purpose of this study is to clear the Safety and Necessity of the Magnetic Resonance Imaging (MRI) in the Presence of CIEDs(Cardiovascular Implantable Electronic Devices).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2067
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The raise of Impedance Threshold of the Atrial and Ventricle immediate；one month RA sensing amplitude (daily mean): < 1.5 mV or RV sensing amplitude (daily min.): < 2.0 mV immediate；one month The proportion of patients with CIED who need MRI examination two years Serious adverse events two years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms ensure MRI safety with CIEDs like pacemakers or ICDs?
How does MRI compatibility of CIEDs compare to standard-of-care devices in clinical practice?
Which biomarkers correlate with successful MRI outcomes in patients with implanted CIEDs?
What adverse events are associated with MRI use in CIED patients and how are they managed?
Are there alternative imaging modalities for CIED patients compared to MRI?