<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/NCT03786640</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10266</org_study_id>
    <nct_id>NCT03786640</nct_id>
  </id_info>
  <brief_title>Abbott Brady 3T MRI PMCF</brief_title>
  <official_title>Long Term Follow-up of the Tendril STS and Isoflex Leads in Conjunction With the Assurity MRI™ and Endurity MRI™ Pacemakers Within the 3T MRI Environment (Brady 3T MRI PMCF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this post-market, clinical follow up (PMCF) study, is to confirm the&#xD;
      long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or&#xD;
      Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla&#xD;
      Magnetic Resonance Imaging) scan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective, non-randomized, observational study will be conducted at 35 centers&#xD;
      worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be&#xD;
      enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 4, 2019</start_date>
  <completion_date type="Actual">December 18, 2021</completion_date>
  <primary_completion_date type="Actual">November 18, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width</measure>
    <time_frame>from pre- MRI scan to one-month post MRI scan</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan</measure>
    <time_frame>from pre-MRI scan to one-month post-MRI scan</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of MRI-related adverse events</measure>
    <time_frame>from pre- to 12-month post- MRI scan</time_frame>
    <description>including but not limited to, the following:&#xD;
Device (pulse generator) heating resulting in tissue damage in the implant pocket, or patient pocket discomfort, or both.&#xD;
Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three.&#xD;
Loss of pacing or capture in the MRI environment.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3</enrollment>
  <condition>Syncope</condition>
  <condition>Presyncope</condition>
  <condition>Fatigue</condition>
  <condition>Disorientation</condition>
  <condition>Arrythmia</condition>
  <condition>Bradycardia</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <description>Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>3T MRI scan</intervention_name>
    <description>A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.</description>
    <arm_group_label>Single Arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an&#xD;
        Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to&#xD;
        participate in this study. Subjects must meet all eligibility criteria and provide written&#xD;
        informed consent prior to conducting any study procedures not considered standard of care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be willing and able to provide informed consent for study participation&#xD;
             (legal guardian or legally authorized representative is NOT acceptable).&#xD;
&#xD;
          2. Subject must be implanted with a St. Jude Medical Tendril STS 2088 or Isoflex&#xD;
             1944/1948 lead, and Assurity MRI or Endurity MRI pacemaker.&#xD;
&#xD;
          3. Capture threshold is stable and &lt; 2.5V @ 0.5ms at the time of enrollment.&#xD;
&#xD;
          4. Subject is clinically indicated for a 3T MRI scan without sedation NOTE: Antianxiety&#xD;
             agents (e.g. minor tranquilizers, etc.) may be used as long as the patient can&#xD;
             communicate with site personnel during the MRI scan&#xD;
&#xD;
          5. Subject is willing and able to comply with the prescribed follow-up tests and schedule&#xD;
             of evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The subject is currently participating in a clinical investigation that includes an&#xD;
             active treatment arm that may confound the results of this study as determined by&#xD;
             Abbott.&#xD;
&#xD;
          2. The subject is &lt;18 years old (pediatric).&#xD;
&#xD;
          3. That subject has a life expectancy of less than 12 months due to any condition.&#xD;
&#xD;
          4. Pregnant or nursing subjects and those who plan pregnancy during the clinical&#xD;
             investigation follow-up period.&#xD;
&#xD;
          5. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             subject's ability to participate in the clinical investigation or to comply with&#xD;
             follow-up requirements, or impact the scientific soundness of the clinical&#xD;
             investigation results.&#xD;
&#xD;
          6. Any contraindication to MRI scan, including the presence of additional hardware (e.g.&#xD;
             lead extenders, lead adapters, surgical staples, stents, dental braces, or abandoned&#xD;
             leads).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tartu University Hospital</name>
      <address>
        <city>Tartu</city>
        <zip>50406</zip>
        <country>Estonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Hopital de Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <state>Brittany</state>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Cardiovasculaire et Pneumologique Louis Pradel</name>
      <address>
        <city>Lyon</city>
        <state>Rhone-alpes</state>
        <zip>69394</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Care Institute of Medical Sciences</name>
      <address>
        <city>Ahmedabad</city>
        <state>Gurarat</state>
        <zip>380060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eternal Haert Care Centre</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apollo Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600 006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Federico II - Università degli Studi di Napoli</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Leeuwarden</name>
      <address>
        <city>Leeuwarden</city>
        <state>Friesland</state>
        <zip>8934 AD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweiter Ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <state>Zuid-Holland</state>
        <zip>3318 AT</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Estonia</country>
    <country>France</country>
    <country>India</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3 Tesla MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Syncope</mesh_term>
    <mesh_term>Confusion</mesh_term>
    <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/NCT03786640
org study id: ABT-CIP-10266
nct id: NCT03786640
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this post-market, clinical follow up (PMCF) study, is to confirm the
      long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or
      Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla
      Magnetic Resonance Imaging) scan.
This prospective, non-randomized, observational study will be conducted at 35 centers
      worldwide where the study devices have 3T MR Conditional labeling; up to 110 patients will be
      enrolled, and will satisfy the recent PMCF requirement to maintain the CE mark.
observational model: Case-Only
time perspective: Prospective
measure: Proportion of subjects with a capture threshold increase of ≤ 0.5V at the permanently programmed pulse width
time frame: from pre- MRI scan to one-month post MRI scan
measure: Proportion of subjects with a sensing amplitude decrease of ≤ 50% from pre-MRI scan to one-month post-MRI scan
time frame: from pre-MRI scan to one-month post-MRI scan
measure: Rate of MRI-related adverse events
time frame: from pre- to 12-month post- MRI scan
description: including but not limited to, the following:
Device (pulse generator) heating resulting in tissue damage in the implant pocket, or patient pocket discomfort, or both.
Induced currents on leads resulting in continuous capture, VT/VF, hemodynamic collapse, or all three.
Loss of pacing or capture in the MRI environment.
arm group label: Single Arm
description: Patients implanted with an SJM Tendril STS 2088 or Isoflex 1944/1948 lead, together with an Assurity MRI or Endurity MRI pacemaker, and who will undergo a 3T MRI scan are eligible to participate in this study.
intervention type: Radiation
intervention name: 3T MRI scan
description: A clinically indicated 3T MRI scan will be performed per standard procedures for the radiology department. Cardiac monitoring during the MRI scan is recommended to include Pulse Oximetry and/or ECG.
arm group label: Single Arm
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Estonia
country: France
country: India
country: Italy
country: Netherlands
responsible party type: Sponsor
mesh term: Syncope
mesh term: Confusion
mesh term: Bradycardia