Mayo Clinic Cardiac Implantable Electronic Device MRI Registry

June 8, 2022 updated by: Robert E. Watson, Mayo Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients at Mayo Clinic who have a previously implanted CIED and are scheduled for a clinically-indicated MRI will be included in the registry.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MRI Scan
Patients with a previously implanted Cardiac Implantable Electronic Device who are undergoing an MRI Scan for clinically indicated, diagnostic purposes.
Radiation: MRI Scan
MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight
Other Names:
  • Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac Implantable Electronic Device Lead Impedance at Different Timepoints
Time Frame: Baseline, Visit 1, 3 months, 6 months
Baseline, Visit 1, 3 months, 6 months
Cardiac Implantable Electronic Device Lead Threshold at Different Timepoints
Time Frame: Baseline, Visit 1, 3 months, 6 months
Baseline, Visit 1, 3 months, 6 months
P/R Wave Amplitude at Different Timepoints
Time Frame: Baseline, Visit 1, 3 months, 6 months
Baseline, Visit 1, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Paul A Friedman, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

April 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

June 10, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 14-001925

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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