<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/NCT04478773</url>
  </required_header>
  <id_info>
    <org_study_id>2020-43</org_study_id>
    <nct_id>NCT04478773</nct_id>
  </id_info>
  <brief_title>Adverse Events of MRI With Abandoned Leads</brief_title>
  <official_title>Evaluating MRI Scanning in Patients With Fractured or Abandoned Endocardial Leads</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lancaster General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lancaster General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of MRI scanning in patients&#xD;
      with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide&#xD;
      community-acquired data that can be used in Medicare and Medicaid coverage determinations and&#xD;
      to investigate whether patients with fractured or abandoned leads can safely be scanned using&#xD;
      an MRI and to evaluate the impact of MRI availability on patient care in this population.&#xD;
      This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of&#xD;
      the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned&#xD;
      lead patient population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2027</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads</measure>
    <time_frame>2 hours</time_frame>
    <description>Incidence of symptoms and adverse events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads.&#xD;
The following measures will be collected twice during the MRI scan and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Proportion/percentage of participants with:&#xD;
Pulling in pocket&#xD;
Chest pain&#xD;
Burning in pocket&#xD;
Palpitations&#xD;
Shortness of breath&#xD;
Other&#xD;
Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with:&#xD;
Atrial fibrillation&#xD;
Ventricular arrhythmias&#xD;
Frequent premature ventricular contractions with hemodynamic instability&#xD;
Symptomatic bradycardia with heart rate less than 40 beats per minute</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Understand longitudinal utilization and safety of subsequent MRIs</measure>
    <time_frame>7 years</time_frame>
    <description>The second component of the study allows subjects to re-enroll for subsequent MRI scans as ordered by their physician to understand utilization and safety.&#xD;
The following measures will be collected and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider :&#xD;
Patient Reported Symptoms - collected twice during the MRI scan.&#xD;
Number of participants with a subsequent MRI that experience:&#xD;
pulling in pocket&#xD;
chest pain&#xD;
burning in pocket&#xD;
palpitations&#xD;
shortness of breath&#xD;
Other&#xD;
Adverse Events - collected via device monitor after MRI scan. Number of participants with:&#xD;
atrial fibrillation&#xD;
ventricular arrhythmias&#xD;
frequent premature ventricular contractions with hemodynamic instability&#xD;
symptomatic bradycardia with heart rate less than 40 beats per minute</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pacemaker Electrode Lead Fracture</condition>
  <condition>ICD</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will receive MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>MRI with or without contrast</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Patients implanted with or without an ICD or pacemaker and with a fractured or an&#xD;
             abandoned or non-functional endocardial lead, and who have a clinical need for MR&#xD;
             imaging&#xD;
&#xD;
          -  Patients are English or Spanish speaking and able to review and sign the consent&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients who complete the MRI standard screening form and are deemed inappropriate for&#xD;
             MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.&#xD;
&#xD;
          -  Patients less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandeep Bansal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Heart Group</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Hivner, M.Ed</last_name>
    <phone>7175441777</phone>
    <email>Elizabeth.Hivner@pennmedicine.upenn.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jonathan Derr, MBA</last_name>
    <phone>7175441777</phone>
    <email>Jonathan.Derr@pennmedicine.upenn.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Lancaster General Health</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elizabeth Hivner</last_name>
      <phone>717-544-1777</phone>
      <email>Elizabeth.Hivner@pennmedicine.upenn.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jonathan Derr</last_name>
      <phone>7175441777</phone>
      <email>Jonathan.Derr@pennmedicine.upenn.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Sandeep Bansal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>January 30, 2023</last_update_submitted>
  <last_update_submitted_qc>January 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>abandoned lead</keyword>
  <keyword>fractured lead</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT04478773/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04478773
org study id: 2020-43
nct id: NCT04478773
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to determine the safety and efficacy of MRI scanning in patients
      with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide
      community-acquired data that can be used in Medicare and Medicaid coverage determinations and
      to investigate whether patients with fractured or abandoned leads can safely be scanned using
      an MRI and to evaluate the impact of MRI availability on patient care in this population.
      This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of
      the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned
      lead patient population.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Incidence of Adverse Events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads
time frame: 2 hours
description: Incidence of symptoms and adverse events related to Magnetic Resonance Imaging (MRI) in patients with abandoned or fractured pacemaker or implantable cardioverter defibrillator (ICD) leads.
The following measures will be collected twice during the MRI scan and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider. Proportion/percentage of participants with:
Pulling in pocket
Chest pain
Burning in pocket
Palpitations
Shortness of breath
Other
Adverse Events - collected via device monitor after MRI scan. Proportion/percentage of participants with:
Atrial fibrillation
Ventricular arrhythmias
Frequent premature ventricular contractions with hemodynamic instability
Symptomatic bradycardia with heart rate less than 40 beats per minute
measure: Understand longitudinal utilization and safety of subsequent MRIs
time frame: 7 years
description: The second component of the study allows subjects to re-enroll for subsequent MRI scans as ordered by their physician to understand utilization and safety.
The following measures will be collected and reported via patient questionnaire and reported observation by technologist and electrophysiology physician or advance practice provider :
Patient Reported Symptoms - collected twice during the MRI scan.
Number of participants with a subsequent MRI that experience:
pulling in pocket
chest pain
burning in pocket
palpitations
shortness of breath
Other
Adverse Events - collected via device monitor after MRI scan. Number of participants with:
atrial fibrillation
ventricular arrhythmias
frequent premature ventricular contractions with hemodynamic instability
symptomatic bradycardia with heart rate less than 40 beats per minute
arm group label: Experimental
arm group type: Experimental
description: Patient will receive MRI
intervention type: Procedure
intervention name: MRI
description: MRI with or without contrast
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sandeep Bansal, MD
role: Principal Investigator
affiliation: The Heart Group
last name: Elizabeth Hivner, M.Ed
phone: 7175441777
email: Elizabeth.Hivner@pennmedicine.upenn.edu
last name: Jonathan Derr, MBA
phone: 7175441777
email: Jonathan.Derr@pennmedicine.upenn.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 