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Trial record 1 of 1 for:    02888353
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Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators

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ClinicalTrials.gov Identifier: NCT02888353
Recruitment Status : Enrolling by invitation
First Posted : September 5, 2016
Last Update Posted : February 6, 2019
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:

Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary.

Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting.

This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.


Condition or disease Intervention/treatment Phase
Device:MRI Device: Device: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Expanded Evaluation of the Safety of Clinically Indicated Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Device: MRI no pre-screen

Clinically Indicated MRI will be done in patients with cardiac devices (pacemakers and defibrillators).

Patients will not be pre-screened prior to hospital visit.

Device: Device: MRI
Perform MRI in patients with cardiac devices




Primary Outcome Measures :
  1. acute patient safety and device malfunction [ Time Frame: 1 hour ]
    Number of participants with >30% change pre vs. post MRI in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms), as a measure of safety


Secondary Outcome Measures :
  1. chronic patient safety and device malfunction [ Time Frame: 1 to 6 weeks ]
    Number of participants with >30% change in each of the following (pacing volts, sensing amplitude, battery life, and impedance (ohms) 1 to 6 weeks post MRI as a measure of safety



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients implanted an ICD or pacemaker who have a clinical need for MR imaging

Exclusion Criteria:

  • Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888353


Locations
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United States, Maryland
Johns Hopkins Hospital, Zayed 5 MRI
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Yale University
Investigators
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Principal Investigator: Henry R Halperin, MD/MA Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02888353    
Other Study ID Numbers: IRB00068447
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Johns Hopkins University:
Magnetic Resonance Imaging and Pacemakers ICD