Safety of Magnetic Resonance Imaging in Non-MRI Conditional Pacemakers and ICD Devices

Last updated: September 14, 2016
Sponsor: Banner Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT02906189
1608820677
  • Ages 18-85
  • All Genders

Study Summary

The primary objective of the study is to determine the safety of MRI in patients with non-MRI conditional pacemakers. The secondary objective is to determine if there are clinically relevant parameter changes in the devices.

Eligibility Criteria

Inclusion

Inclusion Criteria. All patients with non-MRI conditional pacemakers and ICDs between the ages of 18-85 will be eligible to participate. Medical records will be reviewed to confirm the date and make/model of device implanted. Ordering physician discusses the MRI request with radiologist, documenting that there is no appropriate alternate imaging test. Patient must have an appointment with a cardiologist/electrophysiologist prior to MRI. Banner Health policy for standard of care guidelines involving patients receiving MRI's will be followed.

Exclusion Criteria. Patients will be excluded from MRI based on the Department of Radiology protocol. Additional exclusion criteria include: ICD and pacemaker dependent, Pacemaker inserted before 2002, Epicardial leads, fractured leads, abandoned leads, or temporary pacemakers (post-coronary artery bypass graft temporary epicardial pacing wires are acceptable), Patient not awake or unable communicate, Battery voltage at elective replacement interval, implanted non-MRI conditional device (other than pacemaker/ICD).

Study Design

Total Participants: 1500
Study Start date:
September 01, 2016
Estimated Completion Date:
September 30, 2021

Connect with a study center

  • Banner University Medical Center Phoenix

    Phoenix, Arizona 85004
    United States

    Active - Recruiting

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