<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/NCT02195024</url>
  </required_header>
  <id_info>
    <org_study_id>PMUN-DB-001-MRIPM</org_study_id>
    <nct_id>NCT02195024</nct_id>
  </id_info>
  <brief_title>Cardiac MRI After Pacemaker Replacement</brief_title>
  <acronym>MRI-rePACE</acronym>
  <official_title>Cardiac MRI After Replacement of Long Term Implanted PACEmakers by a MRI Conditional Pulse Generator (MRI-rePace)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr. Dirk Bastian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Paracelsus Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI)&#xD;
      in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker&#xD;
      system, to assess MR-image quality and to prove the safety of MRI in this specific population&#xD;
      in the short term as well as during long term follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is designed&#xD;
&#xD;
        1. To investigate the cardiac MRI related adverse event-free rate in patients with long&#xD;
           term implanted coradial pacing leads (Fineline-II) after implantable pulse generator&#xD;
           (IPG) exchange to a MRI conditional system (short term and long term): Safety.&#xD;
&#xD;
        2. To assess the technical performance of MRI conditional pacemaker systems with long term&#xD;
           implanted coradial pacing leads, for cardiac MRI (short term and long term):&#xD;
           Effectiveness pacemaker.&#xD;
&#xD;
        3. To assess the image quality (IQ) and the diagnostic value (DV) of the cardiac MRI scans&#xD;
           in patients with implanted MRI conditional systems: Effectiveness cardiac MRI.&#xD;
&#xD;
           2) To evaluate the clinical incidence of MRI procedures in the population of long term&#xD;
           implanted pacemaker patients (long term-follow up)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI changed affiliation not beening allowed to continue the trial in further cooperation. The&#xD;
    sub-investigators did not see any option to continue the trial and made the decision to&#xD;
    terminate the study.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>safety: cardiac MRI and pacing system related Serious Adverse Device Effects</measure>
    <time_frame>3 months after cardiac MRI</time_frame>
    <description>Primary outcome measure 1 (safety):&#xD;
cMRI and pacing system related Serious Adverse Device Effect (SADE) free rate after 3 months.&#xD;
Hypothesis: MRI and pacing system related Serious Adverse Device Effect (SADE) free-Rate is greater than 90% after 3 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV)</measure>
    <time_frame>cMRI images done ≥ six (6) weeks after device exchange</time_frame>
    <description>Primary outcome measure 2 (Effectiveness cardiac MRI):&#xD;
cMRI image quality (IQ) and diagnostic value (DV)&#xD;
Hypothesis: cMRI IQ is &quot;acceptable&quot; and clinical use is not adversely affected in ≥ 90% cMRI procedures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cMRI and pacing system related Adverse Device Effect</measure>
    <time_frame>1 and 3 months after cardiac MRI</time_frame>
    <description>The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)</measure>
    <time_frame>1 and 3 Months after cardiac MRI</time_frame>
    <description>The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold at post-MRI interrogation, at 1-month and at 3 month follow- up&#xD;
The proportion of patients with an atrial or ventricular MRI induced pacing threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between pre-MRI and at post-MRI interrogation, 1 month and at 3-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude</measure>
    <time_frame>between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI</time_frame>
    <description>- P and R-wave sensing attenuation:&#xD;
o The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI evaluation and at post-MRI interrogation, at 1-month and at 3-month follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Long term pacing capture threshold rise (atrial and ventricular)</measure>
    <time_frame>Pre-MRI interrogation and at 2 years follow- up</time_frame>
    <description>The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold between Pre-MRI interrogation and at 2 years follow- up&#xD;
The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between Pre-MRI interrogation and at 2 years follow- up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>- Long term P and R-wave sensing attenuation</measure>
    <time_frame>between Pre-MRI interrogation and 2 years follow-up</time_frame>
    <description>The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI interrogation and 2 years follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MRI procedures during long term-follow up</measure>
    <time_frame>during a minimum of 2 years follow-up</time_frame>
    <description>Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>periprocedural cardiac troponin</measure>
    <time_frame>pre- and within 3 to 24 hours post-MRI</time_frame>
    <description>Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury</description>
  </secondary_outcome>
  <other_outcome>
    <measure>cMRI periprocedural observations / complaints</measure>
    <time_frame>during cardiac MRI between pre- and post-MRI pacemaker interrogation</time_frame>
    <description>Periprocedural observations / complaints during MRI&#xD;
- Time interval: during MRI scanning, between pre- and post-MRI pacemaker interrogation</description>
  </other_outcome>
  <other_outcome>
    <measure>IPG dysfunction</measure>
    <time_frame>after cMRI at any follow-up until the end of the trial (minimum 24 months)</time_frame>
    <description>- Any IPG dysfunction (reset, reprogramming, over/undersensing, over-/underpacing, exit-block, loss of capture…), Battery changes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Bradycardia</condition>
  <condition>Cardiac Pacemaker</condition>
  <condition>Magnetic Resonance Imaging</condition>
  <arm_group>
    <arm_group_label>cardiac MRI group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No MRI group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>cardiac MRI group</intervention_name>
    <description>• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange</description>
    <arm_group_label>cardiac MRI group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Approved clinical indication for pectoral pacemaker exchange (e.g. elective&#xD;
             replacement indication (ERI), end of service (EOS))&#xD;
&#xD;
          -  Implantation of a CE certified / market released MRI conditional pacemaker (BSCI)&#xD;
             consistent of&#xD;
&#xD;
               -  a single or dual chamber MRI conditional pacemaker (BSCI) or&#xD;
&#xD;
               -  Any comparable successor IPG (MRI conditional system, BSCI) compatible with&#xD;
&#xD;
          -  Implanted Fineline-II-leads (BSCI), MRI conditional&#xD;
&#xD;
          -  Leads electrically intact and with stable and normal function&#xD;
&#xD;
               -  The ascertained lead impedance is between 200 and 1500 Ohm.&#xD;
&#xD;
               -  All pacing capture thresholds (PCT) do not exceed 2.0 V @0.4 or 0.5 ms in&#xD;
                  pacemaker dependent patients&#xD;
&#xD;
          -  Adherence to the MRI conditions of use is given&#xD;
&#xD;
               -  Male or female 18 years or older&#xD;
&#xD;
               -  Understand the nature of the procedure&#xD;
&#xD;
               -  Give written informed consent&#xD;
&#xD;
               -  Able to complete all testing required by the clinical protocol&#xD;
&#xD;
               -  Ability to measure atrial and/or ventricular pacing threshold(s) at 0.4 or 0.5 ms&#xD;
&#xD;
               -  Patient body height greater or equal to 140 cm&#xD;
&#xD;
               -  Pectoral implanted device&#xD;
&#xD;
               -  Subjects who are able and willing to undergo elective cardiac magnetic resonance&#xD;
                  (MR) scanning without sedation (MRI-group)&#xD;
&#xD;
               -  Subjects who are geographically stable and available for follow-up at the study&#xD;
                  center for the length of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Non MRI conditional leads implanted&#xD;
&#xD;
               -  Pacing threshold(s) (at 0.4 or 0.5 ms) and/or sensing amplitude(s) and/or&#xD;
                  impedance(s) are not measurable&#xD;
&#xD;
               -  Meet one or more of the contraindications for MRI including Psychiatric&#xD;
                  disorders, anxiety, claustrophobia Cardiac disorders that represent a&#xD;
                  contraindication to MRI&#xD;
&#xD;
               -  Cardiac surgery already scheduled in the next three months&#xD;
&#xD;
               -  Have other medical implants that may interact with MRI, e.g. abandoned&#xD;
                  implantable cardioverter defibrillator (ICD) leads or pacemaker leads other than&#xD;
                  MRI conditional, lead extensions, other active medical devices, non-MRI&#xD;
                  compatible devices, mechanical valve&#xD;
&#xD;
               -  Have other metallic artifacts/components in body that may interact with MRI&#xD;
&#xD;
               -  Subjects for whom a single dose of 1.0 milligram (mg) dexamethasone acetate may&#xD;
                  be contraindicated&#xD;
&#xD;
               -  Subjects who require a legally authorized representative to obtain consent&#xD;
&#xD;
               -  Subjects who are immediate candidates for an ICD&#xD;
&#xD;
               -  Subjects with medical conditions that preclude the testing required by the&#xD;
                  protocol or limit study participation&#xD;
&#xD;
               -  Subjects who are enrolled or intend to participate in another clinical trial (of&#xD;
                  an investigational drug or device, new indication for an approved drug or device,&#xD;
                  or requirement of additional testing beyond standard clinical practice) during&#xD;
                  this clinical study&#xD;
&#xD;
               -  Being pregnant&#xD;
&#xD;
               -  Have a life expectancy of less than three months&#xD;
&#xD;
               -  Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Bastian, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Paracelsus Medical University Nürnberg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Nürnberg Süd</name>
      <address>
        <city>Nürnberg</city>
        <zip>D-90471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 21, 2014</study_first_posted>
  <last_update_submitted>January 9, 2021</last_update_submitted>
  <last_update_submitted_qc>January 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Paracelsus Medical University</investigator_affiliation>
    <investigator_full_name>Dr. Dirk Bastian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pacemaker</keyword>
  <keyword>magnetic resonance imaging</keyword>
  <keyword>MRI conditional</keyword>
  <keyword>pacemaker leads</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bradycardia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02195024
org study id: PMUN-DB-001-MRIPM
nct id: NCT02195024
lead sponsor: 
collaborator: 
has dmc: No
Aim of this trial is to investigate feasibility of cardiac magnetic resonance imaging (cMRI)
      in patients with long term implanted coradial leads upgraded to an MRI conditional pacemaker
      system, to assess MR-image quality and to prove the safety of MRI in this specific population
      in the short term as well as during long term follow-up.
The trial is designed

        1. To investigate the cardiac MRI related adverse event-free rate in patients with long
           term implanted coradial pacing leads (Fineline-II) after implantable pulse generator
           (IPG) exchange to a MRI conditional system (short term and long term): Safety.

        2. To assess the technical performance of MRI conditional pacemaker systems with long term
           implanted coradial pacing leads, for cardiac MRI (short term and long term):
           Effectiveness pacemaker.

        3. To assess the image quality (IQ) and the diagnostic value (DV) of the cardiac MRI scans
           in patients with implanted MRI conditional systems: Effectiveness cardiac MRI.

           2) To evaluate the clinical incidence of MRI procedures in the population of long term
           implanted pacemaker patients (long term-follow up)
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: safety: cardiac MRI and pacing system related Serious Adverse Device Effects
time frame: 3 months after cardiac MRI
description: Primary outcome measure 1 (safety):
cMRI and pacing system related Serious Adverse Device Effect (SADE) free rate after 3 months.
Hypothesis: MRI and pacing system related Serious Adverse Device Effect (SADE) free-Rate is greater than 90% after 3 months.
measure: Effectiveness cardiac MRI: cMRI image quality (IQ) and diagnostic value (DV)
time frame: cMRI images done ≥ six (6) weeks after device exchange
description: Primary outcome measure 2 (Effectiveness cardiac MRI):
cMRI image quality (IQ) and diagnostic value (DV)
Hypothesis: cMRI IQ is "acceptable" and clinical use is not adversely affected in ≥ 90% cMRI procedures
measure: cMRI and pacing system related Adverse Device Effect
time frame: 1 and 3 months after cardiac MRI
description: The proportion of patients with a cMRI and pacing system related Adverse Device Effect (ADE)
measure: Pacemaker performance under/after MRI (short and midterm) - Pacing capture threshold (PCT) rise (atrial and ventricular)
time frame: 1 and 3 Months after cardiac MRI
description: The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold at post-MRI interrogation, at 1-month and at 3 month follow- up
The proportion of patients with an atrial or ventricular MRI induced pacing threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between pre-MRI and at post-MRI interrogation, 1 month and at 3-month follow-up
measure: Pacemaker performance under/after MRI (short and midterm): atrial or ventricular sensing amplitude
time frame: between Pre-MRI evaluation and at post-MRI interrogation at 1-month and at 3-month follow-up after cMRI
description: - P and R-wave sensing attenuation:
o The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI evaluation and at post-MRI interrogation, at 1-month and at 3-month follow-up
measure: - Long term pacing capture threshold rise (atrial and ventricular)
time frame: Pre-MRI interrogation and at 2 years follow- up
description: The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 100% voltage safety margin of the measured Pre-MRI pacing threshold between Pre-MRI interrogation and at 2 years follow- up
The proportion of patients with an atrial or ventricular MRI induced pacing capture threshold rise larger than or equal to 1.0 V @ 0.4 ms or 0.5 ms between Pre-MRI interrogation and at 2 years follow- up
measure: - Long term P and R-wave sensing attenuation
time frame: between Pre-MRI interrogation and 2 years follow-up
description: The proportion of patients with an atrial or ventricular amplitude decrease that exceed 50% between Pre-MRI interrogation and 2 years follow-up
measure: MRI procedures during long term-follow up
time frame: during a minimum of 2 years follow-up
description: Clinical incidence of MRI procedures during long term-follow up, device performance after repetitive MRI procedures
measure: periprocedural cardiac troponin
time frame: pre- and within 3 to 24 hours post-MRI
description: Cardiac high sensitive Troponin pre- and post-MRI as marker of thermal injury
measure: cMRI periprocedural observations / complaints
time frame: during cardiac MRI between pre- and post-MRI pacemaker interrogation
description: Periprocedural observations / complaints during MRI
- Time interval: during MRI scanning, between pre- and post-MRI pacemaker interrogation
measure: IPG dysfunction
time frame: after cMRI at any follow-up until the end of the trial (minimum 24 months)
description: - Any IPG dysfunction (reset, reprogramming, over/undersensing, over-/underpacing, exit-block, loss of capture…), Battery changes
arm group label: cardiac MRI group
arm group type: Active Comparator
description: • All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
arm group label: No MRI group
arm group type: No Intervention
description: Patients that refuse to undergo cMRI for any reason but accept to attend the trial can be further observed according to the protocol
intervention type: Procedure
intervention name: cardiac MRI group
description: • All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
arm group label: cardiac MRI group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dirk Bastian, MD
role: Principal Investigator
affiliation: Paracelsus Medical University Nürnberg
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: Paracelsus Medical University
investigator full name: Dr. Dirk Bastian
investigator title: Principal Investigator
mesh term: Bradycardia