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Cardiac Implantable Electronic Device Magnetic Resonance Imaging Registry

NCT02459379 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2017-11-09

No results posted yet for this study

Summary

This is a prospective registry evaluating the safety of performing magnetic resonance (MRI) scans on patients who have cardiac implanted electronic devices (CIEDs). This includes pacemakers and implantable cardioverter defibrillators (ICDs). This is not a a new device approval or new MRI scanner approval, only for a registry of patients who need to have an MRI scan who already have an FDA approved CIED that is not currently labeled for use in conjunction with an MRI scan. This registry is very similar to the previously approved MagnaSafe Registry that is now closed to new enrollment.

Conditions

  • Pacemaker Malfunction
  • Implantable Defibrillator Malfunction

Interventions

RADIATION

MRI Scan

MRI will be performed for clinical reason for which no other imaging study will provide the data required on patients with pacemaker or implantable defibrillator

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-04-01
Completion
2017-04-01
FDA Device
Yes

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Entities

Companies

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 NCT02459379 on ClinicalTrials.gov