Registry Study of Clinical Application of MRI Compatible CIED

Biotronik

Status: Completed

Conditions: Need for MRI Imaging With Pacemaker or Implantable Cardioverter Defibrillator Implanted

Study type: Observational

Funder types: Industry

Identifiers

NCT02380300

2015-01

Details and patient eligibility

About

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).

Enrollment: 2,067 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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