Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
Conditions
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).
Interventions
None listed
Sponsors
Biotronik (Beijing) Medical Device Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion criteria * Patient is \>18 years old * Patient implanted with a Biotronik MRI compatible CIED (including the pacemaker, cardiac resynchronization therapy, implantable cardioverter defibrillator, and cardiac resynchronization therapy-defibrillator) in the past two months * Patient has provided a written informed consent * Patient's height is≥140cm 2.
Exclusion criteria
* Have other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices * Life expectancy less than 2 years * Pregnant and/or breat-feeding females or females who intend to become pregnant in next two years * Patient is currently participating in another study * In the investigator's opinion patient will not be able to comply with the follow-up requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed