Skip to main content
OpenTrials
Completed

NCT Number: NCT02357082

Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Magnetic Resonance Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI Scan

Radiation

MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight

Other names: Magnetic Resonance Imaging

Primary outcomes

  1. Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints

    Time frame: Baseline, Visit 1, 3 months, 6 months

  2. Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints

    Time frame: Baseline, Visit 1, 3 months, 6 months

  3. P/R Wave Amplitude at Different Timepoints

    Time frame: Baseline, Visit 1, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Mayo Clinic Cardiac Implantable Electronic Device (CIED) Magnetic Resonance Imaging (MRI) Registry; Determining the Risks of of MRI in the Presence of Cardiac Implantable Electronic Devices

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2015
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.