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 Serious adverse events two years 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
- Secondary Outcome Measures
Name Time Method