Study to Monitor Patients With Pacemakers or ICDs Who Undergo MRI Scans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01999751
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Michael Mollerus, Essentia Health

Brief Summary:
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.

Condition or disease Intervention/treatment
Arrhythmias, Cardiac Device: MRI Scan

  Show Detailed Description

Study Type : Observational [Patient Registry]
Actual Enrollment : 124 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: SMDC CRM-MRI Prospective Case Series
Study Start Date : October 2012
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 11, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
MRI Scan
Patients with implantable cardioverter-defibrillator or pacemaker who undergo an MRI scan
Device: MRI Scan
Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.

Primary Outcome Measures :
  1. Pacing threshold increase [ Time Frame: 12 months ]
    Any change greater than 1 V at a pulse width of 0.5 msec in a pacemaker or implantable cardioverter-defibrillator lead at any time within 12 months of the MRI scan

Secondary Outcome Measures :
  1. Ectopy [ Time Frame: 1 hour ]
    Increased cardiac ectopy at the time of the MRI scan

  2. Pacemaker reprogramming [ Time Frame: 12 months ]
    Unanticipated pacemaker or implantable cardioverter-defibrillator reprogramming because of alterations in device behavior possibly related to the MRI scan

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person followed at St. Mary's Medical Center, Duluth, MN, with a permanent pacemaker or implantable cardioverter-defibrillator implanted for at least 6 weeks, referred for a medically-required MRI scan by a physician or provider not participating in the trial. If patients elect not to participate, they may still receive an MRI and will sign the clinical consent. If they elect not to have an MRI, they will be referred back to the ordering provider to discuss other options.

Inclusion Criteria:

  1. Permanent Pacemaker or ICD implanted for at least 6 weeks
  2. Referred for medically-required MRI scan
  3. Age greater than or equal to 18 years

Exclusion Criteria:

  1. ICD market released before 2001 including GDT Ventak-AV, GDT MINI-II, GDT MINI-IV, GDT MINI-III, GDT Prizm, GDT Prizm-2 and MDT GEM-I series
  2. Epicardial lead or subcutaneous array
  3. Device has reached elective replacement indicator (ERI) or end of life (EOL)
  4. Other usual contraindications to MRI scanning
  5. Known or suspected lead fracture or abandoned lead
  6. Pacemaker dependent patients with an ICD that cannot be programmed to asynchronous pacing (DOO/VOO)
  7. Clinical factors that are deemed by the PI or Sub-I to increase the participant's risk above an acceptable clinical threshold

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01999751

United States, Minnesota
St. Mary's Medical Center
Duluth, Minnesota, United States, 55812
Sponsors and Collaborators
Essentia Health
Principal Investigator: Michael E Mollerus, MD Essentia Health


Responsible Party: Michael Mollerus, Physician, Essentia Health Identifier: NCT01999751     History of Changes
Other Study ID Numbers: EH12274
First Posted: December 3, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by Michael Mollerus, Essentia Health:
Magnetic Resonance Imaging
Pacemaker, Artificial
Defibrillators, Implantable

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes