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

NCT01999751 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2018-04-12

No results posted yet for this study

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.

Conditions

  • Arrhythmias, Cardiac

Interventions

DEVICE

MRI Scan

Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.

Sponsors & Collaborators

  • Essentia Health

    lead OTHER

Principal Investigators

  • Michael E Mollerus, MD · Essentia Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2018-04-02
Completion
2018-04-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01999751 on ClinicalTrials.gov