VAPORHCS/OHSU J: MRI and Devices

NCT03915015 | Recruiting DMC FDA Device

• 1 other identifier: 8423
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

MRI

Outcome Measures

Primary Outcomes (2)

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

  Percent of patients successfully completing MRI scan without complication per interrogation of their device and clinical assessment.

  During MRI scan.

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

  Percent of patients successfully following up after MRI scan without complication per interrogation of their device and clinical assessment.

  1-6 week follow up in device clinic

Study Arms (1)

the study

OTHER

Patients with a PPM or ICD getting a clinically indicated MRI

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

MRI

the study

Eligibility Criteria

• Age: 9 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (2)

Oregon Health and Scince University

Portland, Oregon, 97239, United States

RECRUITING

Portland Veterans Administration Medical Center

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (2)

• Yadava M, Nugent M, Krebsbach A, Minnier J, Jessel P, Henrikson CA. Magnetic resonance imaging in patients with cardiac implantable electronic devices: a single-center prospective study. J Interv Card Electrophysiol. 2017 Oct;50(1):95-104. doi: 10.1007/s10840-017-0262-6. Epub 2017 Jul 22.

  PMID: 28733766 BACKGROUND

• Nazarian S, Hansford R, Roguin A, Goldsher D, Zviman MM, Lardo AC, Caffo BS, Frick KD, Kraut MA, Kamel IR, Calkins H, Berger RD, Bluemke DA, Halperin HR. A prospective evaluation of a protocol for magnetic resonance imaging of patients with implanted cardiac devices. Ann Intern Med. 2011 Oct 4;155(7):415-24. doi: 10.7326/0003-4819-155-7-201110040-00004.

  PMID: 21969340 BACKGROUND

Study Officials

• Charles Henrikson, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Henrikson, MD

CONTACT

503-494-7400; henrikso@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 16, 2019
• Study Start: July 19, 2012
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)