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Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators

NCT02888353 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2025-12-15

No results posted yet for this study

Summary

Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary.

Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting.

This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.

Conditions

  • Device:MRI

Interventions

DEVICE

Device: MRI

Perform MRI in patients with cardiac devices

Sponsors & Collaborators

Principal Investigators

  • Henry R Halperin, MD/MA · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
9 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • United States

Study Locations

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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 NCT02888353 on ClinicalTrials.gov