Assure MRI Study

• Research type

  Research Study

• Full title

  Clinical Study to Confirm MRI Safety and Effectiveness Using SJM Cardiac Rhythm Management Systems

• IRAS ID

  224352

• Contact name

  Roy Gardner

• Contact email

  rsgardner@doctors.org.uk

• Sponsor organisation

  St. Jude Medical

• Clinicaltrials.gov Identifier

  NCT03012568

• Duration of Study in the UK

  0 years, 10 months, 0 days

• Research summary

  The ASSURE MRI Study is a prospective, multi-center clinical study designed to confirm the safety and effectiveness of St. Jude Medical low voltage pacemakers, high voltage dual chamber implantable cardioverter-defibrillators(ICDs), and cardiac resynchronization therapy defibrillators (CRT-Ds) with various leads in an MRI environment.

  A prospective, multi-centre study design is chosen for generalizability of study results.

  The clinical study will be conducted in approximately 40 centres worldwide.
  Approximately 88 subjects total (with a minimum 22 subjects for each of the four device/lead combinations) will be enrolled in this study.

• REC name

  West of Scotland REC 4

• REC reference

  17/WS/0068

• Date of REC Opinion

  13 Jun 2017

• REC opinion

  Further Information Favourable Opinion