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MRI Safety for Pacemaker/Defibrillator Patients

N/A
Recruiting
Led By Charles Henrikson, MD
Research Sponsored by Oregon Health and Science University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must not have
Pregnant patients will be excluded in their first trimester and will not get gadolinium at any time during their pregnancy
Patients who weighing less than 80 lbs.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during mri scan.
Awards & highlights
No Placebo-Only Group

Summary

This trial is looking at whether MRIs are safe for patients with pacemakers or defibrillators.

Who is the study for?
This trial is for patients who need an MRI and have a pacemaker (made after 1996) or defibrillator (made after 2000). It's not for pregnant women in their first trimester, those with old or certain problematic heart device leads, people under 80 lbs, or anyone unsuitable for MRI.
What is being tested?
The study is examining the safety and outcomes of performing medically necessary MRIs on patients with newer models of permanent pacemakers and implantable cardioverter defibrillators.
What are the potential side effects?
Since this trial involves standard MRI procedures, side effects may include discomfort from lying still during the scan, loud noises from the machine, and anxiety. There are no additional side effects expected from the MRI itself.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not in my first trimester of pregnancy and understand I cannot receive gadolinium.
Select...
I weigh less than 80 lbs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-6 week follow up in device clinic
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 week follow up in device clinic for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MRI Safety during MRI scan in patients with PPMs/ICDs.
MRI Safety following MRI scan in patients with PPMs/ICDs.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: the studyExperimental Treatment1 Intervention
Patients with a PPM or ICD getting a clinically indicated MRI
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityLead Sponsor
1,005 Previous Clinical Trials
7,403,387 Total Patients Enrolled
Charles Henrikson, MDPrincipal Investigator - Oregon Health and Science University
Doernbecher Children's Hospital, OHSU Healthcare
Columbia University College Of Physicians And Surgeons (Medical School)
Johns Hopkins University School Medicine (Residency)
5 Previous Clinical Trials
1,167 Total Patients Enrolled

Media Library

the study Clinical Trial Eligibility Overview. Trial Name: NCT03915015 — N/A
Magnetic Resonance Imaging (MRI) Research Study Groups: the study
Magnetic Resonance Imaging (MRI) Clinical Trial 2023: the study Highlights & Side Effects. Trial Name: NCT03915015 — N/A
the study 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915015 — N/A
~3303 spots leftby Dec 2030
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