MRI Safety for Pacemaker and Defibrillator Patients

Recruiting in Baltimore (>99 mi)

Overseen byHenry R Halperin, MD/MA

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with implanted pacemakers or defibrillators who need an MRI scan. Participants must meet standard MRI safety criteria, but unlike previous studies, they won't go through extra vetting because of their devices.

Inclusion Criteria

I have an ICD or pacemaker and need an MRI.

Exclusion Criteria

Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason

Participant Groups

The study tests the safety of performing MRI scans on patients with certain heart devices without prior detailed device checks. It's a large study involving 1,700 participants to see if MRIs can be done safely under these new conditions.

1Treatment groups

Experimental Treatment

Group I: Device: MRI no pre-screenExperimental Treatment1 Intervention

Clinically Indicated MRI will be done in patients with cardiac devices (pacemakers and defibrillators). Patients will not be pre-screened prior to hospital visit.