Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-001925
    NCT ID: NCT02357082
    Sponsor Protocol Number: 14-001925

About this study

Registry intends to prospectively collect data regarding the safety of magnetic resonance imaging (MRI) studies in patients with cardiac pacemakers on implantable cardioverter defibrillators.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology
  • Male or Female
  • 18 years of age or older
  • Able to provide informed consent
  • Presence of CIED

Exclusion Criteria:

  • Presence of metallic objects that represent a contraindication to MR imaging, including: MRI-unsafe intra-orbital or intra-ocular retained metal fragments, and MRI-unsafe intracranial vascular clips and coils, other MRI-unsafe devices
  • Morbid obesity (abdominal diameter greater than 60 centimeters) which results in contact wiht the magnet bore.
  • Pregnant at time of scanning Pacemaker or Implanted Cardiac Device that is labeled as MRI-Conditional (approved by the Food and Drug Administration for exposure to MRI)
  • Pacemaker dependent and either: 1) device implanted before 2005, or 2) advisory pulse generator that may lower outputs in the setting of radiofrequency currents

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Watson, M.D., Ph.D.

Open for enrollment

Contact information:

Terry Brinkman CCRP

(507)284-4377

tbrinkman@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20147444

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