Clinical trial Recruiting at 2 sites Interventional Ages 9 to 99

MRI scans for patients with pacemakers and defibrillators

Official title: VAPORHCS/OHSU J: Safety of Clinically Indicated Magnetic Resonance Imaging in Patients With Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators (ICDs)

Run by Oregon Health and Science University · NCT03915015 · Data updated 2026-11-12

This study is testing whether it's safe to perform MRI scans on patients with pacemakers and defibrillators to help them get the imaging they need.

Quick facts

Study typeInterventional
Ages9 Years to 99 Years
SexAll
Enrollment10000 (estimated)
SponsorOregon Health and Science University
Academic / other
Locations2 sites (Portland, Oregon and 1 other locations)
StatusRecruiting
StartedJuly 19, 2012
Main results expectedDecember 31, 2030
Study endsDecember 31, 2030
Registry record updatedApril 15, 2024
Trial IDNCT03915015 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients with a clinical need for MRI who have pacemakers from 1996 or later and ICDs from 2000 or later.

Probably not a fit

Patients with older pacemaker or ICD models, those who are pacemaker dependent, or those with certain medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety of performing MRI scans on patients who have permanent pacemakers and implantable cardioverter defibrillators (ICDs). It aims to include 1,000 patients at Oregon Health and Science University (OHSU) who have a clinical need for MRI, while adhering to strict safety protocols. The study hypothesizes that with appropriate precautions, MRIs can be safely conducted in these patients, addressing a significant gap in care where many are currently denied necessary imaging. The research will assess the types of devices and leads present in participants to ensure safety during the procedure.

Why it matters

Potential benefit: If successful, this study could allow thousands of patients with implanted devices to receive necessary MRI scans, improving their diagnostic and treatment options.

How similar studies have gone: Previous studies, including those from Johns Hopkins, have shown that MRIs can be safely performed on patients with similar devices when proper precautions are taken.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)

Exclusion Criteria:

* Patients with pacemaker models before 1996 and ICD models before year 2000.
* Pacemaker dependent patients with ICD.
* Patients who weighing less than 80 lbs.
* Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
* Pregnant patients will be excluded in their first trimester and will not get gadolinium at any time during their pregnancy
* Patient with abandoned/capped leads or leads implanted \<4 weeks unless the procedure is deemed critical by the referring physician and approved by the PI

Where it's running

  • Oregon Health and Scince University
    Portland, Oregon, United States
    Recruiting
  • Portland Veterans Administration Medical Center
    Portland, Oregon, United States
    Recruiting

Study contacts

  • Principal investigator: Charles Henrikson, MD — Oregon Health and Science University
  • Study coordinator: Charles Henrikson, MD
  • Email: henrikso@ohsu.edu
  • Phone: 503-494-7400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.