<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02227004</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00051707</org_study_id>
    <nct_id>NCT02227004</nct_id>
  </id_info>
  <brief_title>Safety of Magnetic Resonance Imaging in Patients With Pacemakers and Defibrillators</brief_title>
  <official_title>Safety of Clinically Indicated Magnetic Resonance Imaging in Patients With Permanent Pacemakers (PPM) and Implanted Cardioverter Defibrillators</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to&#xD;
      safety concerns. Recent work in our laboratory as well as our pilot study of approximately&#xD;
      500 patients has shown the safety of most contemporary implanted rhythm management devices in&#xD;
      the MRI environment given appropriate precautions. Because the investigators have completed&#xD;
      testing in animals weighing as little as 80 lbs. without incident, the investigators feel&#xD;
      they can safely image children at this weight or greater (Circulation 2004; 110:475-482).&#xD;
&#xD;
      The goal of this study is to expand on our pilot study and to develop a protocol, consistent&#xD;
      with the Department of Health and Human Services (DHHS) requirements, that will increase our&#xD;
      safety experience with clinically indicated MR imaging in patients with implanted cardiac&#xD;
      pacemakers and ICD's.&#xD;
&#xD;
      This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will&#xD;
      be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the&#xD;
      setting of implantable devices will be discussed and informed consent obtained. The type of&#xD;
      device and leads will be ascertained. Patients will be monitored by a physician or a&#xD;
      Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming&#xD;
      during the study. When imaging children who meet age and weight criteria, a physician will be&#xD;
      present during the entire study. Fellow and attending radiology and electrophysiology support&#xD;
      will be available in house in all cases.&#xD;
&#xD;
      Standard device testing including battery voltages, thresholds, sensing and lead impedances&#xD;
      will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this study is to develop a protocol, consistent with DHHS/ Center&#xD;
      for Medicare and Medicaid Services (CMS) guidelines and requirements to further document&#xD;
      safety in clinically indicated MR imaging in patients with implanted cardioverter&#xD;
      defibrillators (ICD's) and pacemakers.&#xD;
&#xD;
      MRI's will be conducted on patients who require a clinically indicated MRI only. All studies&#xD;
      will be done in the 1.5 Tesla MRI unit. ECG monitoring pads will be placed on the patients&#xD;
      for the duration of the study. An external defibrillator and Advance Cardiovascular Life&#xD;
      Support (ACLS) drugs will be on hand. Heart rate, blood pressure, O2 saturation will also be&#xD;
      monitored non-invasively throughout the study. All devices will undergo a complete&#xD;
      interrogation prior to imaging. Parameters such as atrial and ventricular pacing thresholds,&#xD;
      R and P wave amplitudes, lead impedance, and battery status will be measured and recorded.&#xD;
      PPMs will be programmed to an asynchronous mode if dependent and to an inhibited mode in&#xD;
      patients without pacemaker dependence.&#xD;
&#xD;
      The pacemaker function of ICD's in pacemaker independent patients will be programmed to&#xD;
      ventricular inhibited (VVI) mode at 50 bpm. Pacemaker dependant patients with ICDs will be&#xD;
      excluded.&#xD;
&#xD;
      In addition, there is a theoretical concern that patients who have capped or abandoned leads&#xD;
      in their chest may be at risk for heating. While there is little or no objective data to&#xD;
      support this concern, given this theoretical concern, patients in this category will only be&#xD;
      admitted to the study if the referring physician deems the MRI critical and after the PI has&#xD;
      carefully considered the risk/benefit ration for each patient who falls in to this category.&#xD;
&#xD;
      Similarly, there historically has also been a concern that newly implanted leads (&lt;4 weeks)&#xD;
      are at risk for lead to dislodgement d/t possible torque from the MRI environment. This too&#xD;
      is only a theoretical concern and there is little or no scientific evidence to support this&#xD;
      claim. Nevertheless, patients with newly implanted pacemaker/ICD leads will be considered by&#xD;
      the PI for protocol inclusion only if the referring physician deems the MRI to be critical&#xD;
      and after considering the risk/benefit to each individual patient.&#xD;
&#xD;
      After the appropriate MRI protocol for each MRI patient's unique condition has been&#xD;
      completed, the device will be re-programmed to its original settings and completely&#xD;
      interrogated to detect any changes in device performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 30, 2011</start_date>
  <completion_date type="Actual">January 22, 2015</completion_date>
  <primary_completion_date type="Actual">January 22, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient safety and device malfunction during or after MRI</measure>
    <time_frame>post MRI</time_frame>
    <description>Device function will be assessed by comparing pre-vs. post MRI battery voltage, impedance, sensing and capture thresholds</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1275</enrollment>
  <condition>Conditions Requiring Diagnostic Evaluation</condition>
  <arm_group>
    <arm_group_label>MRI in patients with Pacemaker or ICD</arm_group_label>
    <description>Perform MRI in patients with pacemaker or ICD and evaluate patient and device safety</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Perform MRI in patients with pacemaker or ICD</intervention_name>
    <description>Perform MRI in patients with pacemaker or ICD</description>
    <arm_group_label>MRI in patients with Pacemaker or ICD</arm_group_label>
  </intervention>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Males and females 9 years or older weighing at least 80 lbs&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Males and females 9 years old or greater weighing more than 80 lbs who require a clinically&#xD;
        indicated MRI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later)&#xD;
        or ICD's (year 2000 or later)&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Inclusion: Patients with an absolute clinical need for MR imaging and PPM (year 1996 model&#xD;
        or later) or ICD's (year 2000 or later)&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Patients with pacemaker models before 1996 and ICD models before year 2000.&#xD;
&#xD;
          -  Pacemaker defendant patients with ICD.&#xD;
&#xD;
          -  Patients who weighing less than 80 lbs.&#xD;
&#xD;
          -  Patients less than 9 years old&#xD;
&#xD;
          -  Patients who complete the MRI standard screening form and are deemed inappropriate for&#xD;
             MRI for any reason&#xD;
&#xD;
          -  Pregnant patients will be excluded in their first trimester and will not get&#xD;
             gadolinium at any time during their pregnancy&#xD;
&#xD;
          -  Patient with abandoned/capped leads or leads implanted &lt;4 weeks unless the procedure&#xD;
             is deemed critical by the referring physician and approved by the PI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry R. Halperin, M.D.,M.A.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital, Blalcok 5 MRI</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29281579/</url>
    <description>PubMed Citation #1</description>
  </link>
  <results_reference>
    <citation>Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.</citation>
    <PMID>29281579</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MRI</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <keyword>pacemakers</keyword>
  <keyword>ICD</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02227004
org study id: NA_00051707
nct id: NCT02227004
lead sponsor: 
has dmc: No
Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to
      safety concerns. Recent work in our laboratory as well as our pilot study of approximately
      500 patients has shown the safety of most contemporary implanted rhythm management devices in
      the MRI environment given appropriate precautions. Because the investigators have completed
      testing in animals weighing as little as 80 lbs. without incident, the investigators feel
      they can safely image children at this weight or greater (Circulation 2004; 110:475-482).

      The goal of this study is to expand on our pilot study and to develop a protocol, consistent
      with the Department of Health and Human Services (DHHS) requirements, that will increase our
      safety experience with clinically indicated MR imaging in patients with implanted cardiac
      pacemakers and ICD's.

      This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will
      be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the
      setting of implantable devices will be discussed and informed consent obtained. The type of
      device and leads will be ascertained. Patients will be monitored by a physician or a
      Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming
      during the study. When imaging children who meet age and weight criteria, a physician will be
      present during the entire study. Fellow and attending radiology and electrophysiology support
      will be available in house in all cases.

      Standard device testing including battery voltages, thresholds, sensing and lead impedances
      will be measured.
The primary objective of this study is to develop a protocol, consistent with DHHS/ Center
      for Medicare and Medicaid Services (CMS) guidelines and requirements to further document
      safety in clinically indicated MR imaging in patients with implanted cardioverter
      defibrillators (ICD's) and pacemakers.

      MRI's will be conducted on patients who require a clinically indicated MRI only. All studies
      will be done in the 1.5 Tesla MRI unit. ECG monitoring pads will be placed on the patients
      for the duration of the study. An external defibrillator and Advance Cardiovascular Life
      Support (ACLS) drugs will be on hand. Heart rate, blood pressure, O2 saturation will also be
      monitored non-invasively throughout the study. All devices will undergo a complete
      interrogation prior to imaging. Parameters such as atrial and ventricular pacing thresholds,
      R and P wave amplitudes, lead impedance, and battery status will be measured and recorded.
      PPMs will be programmed to an asynchronous mode if dependent and to an inhibited mode in
      patients without pacemaker dependence.

      The pacemaker function of ICD's in pacemaker independent patients will be programmed to
      ventricular inhibited (VVI) mode at 50 bpm. Pacemaker dependant patients with ICDs will be
      excluded.

      In addition, there is a theoretical concern that patients who have capped or abandoned leads
      in their chest may be at risk for heating. While there is little or no objective data to
      support this concern, given this theoretical concern, patients in this category will only be
      admitted to the study if the referring physician deems the MRI critical and after the PI has
      carefully considered the risk/benefit ration for each patient who falls in to this category.

      Similarly, there historically has also been a concern that newly implanted leads (<4 weeks)
      are at risk for lead to dislodgement d/t possible torque from the MRI environment. This too
      is only a theoretical concern and there is little or no scientific evidence to support this
      claim. Nevertheless, patients with newly implanted pacemaker/ICD leads will be considered by
      the PI for protocol inclusion only if the referring physician deems the MRI to be critical
      and after considering the risk/benefit to each individual patient.

      After the appropriate MRI protocol for each MRI patient's unique condition has been
      completed, the device will be re-programmed to its original settings and completely
      interrogated to detect any changes in device performance.
observational model: Cohort
time perspective: Prospective
measure: Patient safety and device malfunction during or after MRI
time frame: post MRI
description: Device function will be assessed by comparing pre-vs. post MRI battery voltage, impedance, sensing and capture thresholds
arm group label: MRI in patients with Pacemaker or ICD
description: Perform MRI in patients with pacemaker or ICD and evaluate patient and device safety
intervention type: Diagnostic Test
intervention name: Perform MRI in patients with pacemaker or ICD
description: Perform MRI in patients with pacemaker or ICD
arm group label: MRI in patients with Pacemaker or ICD
Males and females 9 years or older weighing at least 80 lbs
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 9 Years
maximum age: 100 Years
healthy volunteers: No
last name: Henry R. Halperin, M.D.,M.A.
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
url: https://pubmed.ncbi.nlm.nih.gov/29281579/
description: PubMed Citation #1
citation: Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.
PMID: 29281579
responsible party type: Sponsor
sharing ipd: No