Registry Study of Clinical Application of MRI Compatible CIED | NCT02380300 | Trialant
CompletedObservationalUpdated Aug 17, 2022
Registry Study of Clinical Application of MRI Compatible CIED
ClinicalTrials.gov ID
NCT02380300
Lead Sponsor
Biotronik (Beijing) Medical Device Ltd.INDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
2,067Actual
Last Update Posted
Aug 17, 2022Actual
Start Date
Mar 15, 2015Actual
Primary Completion Date
Sep 2020Actual
Completion Date
Sep 2020Actual
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).
Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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