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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1700 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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
|United States, Maryland|
|Johns Hopkins Hospital, Zayed 5 MRI|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Henry R Halperin, MD/MA||Johns Hopkins University|