RecruitingNot Applicable

VAPORHCS/OHSU J: MRI and Devices

United States10,000 participantsStarted 2012-07-19

Plain-language summary

This is a database study of clinically indicated MRIs on patients with permanent pacemakers and implantable cardioverter defibrillators.

Who can participate

Age range

9 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MRI Safety during MRI scan in patients with PPMs/ICDs.

Timeframe: During MRI scan.

MRI Safety following MRI scan in patients with PPMs/ICDs.

Timeframe: 1-6 week follow up in device clinic

Trial details

NCT IDNCT03915015

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Charles Henrikson, MD

503-494-7400 henrikso@ohsu.edu

View on ClinicalTrials.gov More MRI trials

Who can participate

Age range

9 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.