Recruiting

MRI & Devices

Sponsor:

Oregon Health and Science University

Code:

NCT03915015

Conditions

MRI

Eligibility Criteria

Sex: All

Age: 9 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI

Study Details

Brief summary:

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

Conditions

MRI

Study ID

NCT03915015

Start date

Jul 19, 2012

Status verified date

Apr, 2024

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: the study

Patients with a PPM or ICD getting a clinically indicated MRI

Interventions

MRI

MRI

Primary outcome measure

  • MRI Safety during MRI scan in patients with PPMs/ICDs. [ Time Frame: During MRI scan. ]
  • MRI Safety following MRI scan in patients with PPMs/ICDs. [ Time Frame: 1-6 week follow up in device clinic ]

Central Contacts and Locations

Central contacts

Charles Henrikson, MD

503-494-7400henrikso@ohsu.edu

Locations

Oregon Health and Scince University

Recruiting

Portland, Oregon, United States, 97239

Portland Veterans Administration Medical Center

Recruiting

Portland, Oregon, United States, 97239

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 15, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2024-04-15.