<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/NCT02235545</url>
  </required_header>
  <id_info>
    <org_study_id>60045220</org_study_id>
    <nct_id>NCT02235545</nct_id>
  </id_info>
  <brief_title>Optisure Lead Post Approval Study</brief_title>
  <official_title>Optisure Lead Post Approval Study</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>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post approval study is to characterize the chronic performance of the SJM&#xD;
      Optisure family of HV leads in patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Abbott received FDA approval to transition the ongoing Optisure PAS to EP a new EP-PASSION Real&#xD;
    World Evidence methodology&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Freedom from RV Lead Related Complications</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optisure Lead-Related Complication Rates</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Optisure Lead Related Adverse Events</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The annual hazard rate of lead electrical dysfunction</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The annual hazard rate of externalized conductors</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The annual hazard rate of other visual lead anomalies by each subcategory</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Prevalence of &quot;other insulation anomalies&quot; in &quot;returned leads</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time from externalized conductors to electrical dysfunction</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time from other visual lead anomalies by each subcategory to electrical dysfunction</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time from externalized conductors to clinical intervention</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Time from other visual lead anomalies by each subcategory to clinical intervention</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Comparison of patients with electrical dysfunction to those without electrical dysfunction.</measure>
    <time_frame>Date at which all patients have completed their five year follow-up.</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1735</enrollment>
  <condition>Heart Failure</condition>
  <condition>Tachycardia, Ventricular</condition>
  <arm_group>
    <arm_group_label>St. Jude Medical Optisure Lead</arm_group_label>
    <description>Patients implanted with St. Jude Medical Optisure Lead</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>St. Jude Medical Optisure Lead</intervention_name>
    <description>Patients implanted with St. Jude Medical Optisure Lead</description>
    <arm_group_label>St. Jude Medical Optisure Lead</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        ICD/CRT-D indicated patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients will meet all of the following:&#xD;
&#xD;
          1. Have an approved indication, as per ACC/AHA/HRS/ESC guidelines, for implantation of an&#xD;
             ICD or CRT-D system for treatment of heart failure or life-threatening ventricular&#xD;
             tachyarrhythmia(s).&#xD;
&#xD;
          2. Have been implanted with a St. Jude Medical Optisure lead in the last 30 days or are&#xD;
             scheduled for an Optisure lead implant.&#xD;
&#xD;
          3. Have the ability to provide informed consent for study participation and be willing&#xD;
             and able to comply with the prescribed follow-up tests and schedule of evaluations.&#xD;
&#xD;
          4. Are 18 years or above, or of legal age to give informed consent specific to state and&#xD;
             national law.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they meet any of the following:&#xD;
&#xD;
          1. Enrolled or intend to participate in a clinical drug and/or device study, which could&#xD;
             confound the results of this trial as determined by SJM, during the course of this&#xD;
             clinical study.&#xD;
&#xD;
          2. Have a life expectancy of less than 5 years due to any condition.&#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>Grant Kim</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Devices</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Medical Center Princeton</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phoenix Cardiovascular Research Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Bernards (formerly Cardiology Associates of Northeast Arkansas)</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Raymond Schaerf, MD</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart Rhythm Consultants</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Rhythm Specialists, Inc.</name>
      <address>
        <city>Reseda</city>
        <state>California</state>
        <zip>91335</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Diego Heart Rhythm Center (formerly San Diego Heart and Vascular Associates)</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jorge Diaz, M.D. , P.A.</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32746</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockford Cardiology Associates</name>
      <address>
        <city>Rockford</city>
        <state>Illinois</state>
        <zip>61107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkview Research Center</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Elizabeth Medical Center - South Unit</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Cardiology Associates</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mass Heart &amp; Rhythm</name>
      <address>
        <city>Leominster</city>
        <state>Massachusetts</state>
        <zip>01453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Premier Medical Clinics</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Regional Medical Center</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Michigan Hospital</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Heart Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of North Mississippi</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Cardiology</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates of the Delaware Valley</name>
      <address>
        <city>Haddon Heights</city>
        <state>New Jersey</state>
        <zip>08035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lourdes Cardiology Services</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian Heart Group</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coney Island Hospital</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Group of Syracuse</name>
      <address>
        <city>Liverpool</city>
        <state>New York</state>
        <zip>13088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Point Regional Health (formerly Carolina Cardiology Cornerstone)</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CarolinaEast Heart Center</name>
      <address>
        <city>New Bern</city>
        <state>North Carolina</state>
        <zip>28562</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center Cleveland</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Medical Research, LLC</name>
      <address>
        <city>Willoughby</city>
        <state>Ohio</state>
        <zip>44094</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integris Baptist Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Heart and Vascular Institute</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lancaster General Hospital</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrhythmia Institute</name>
      <address>
        <city>Newtown</city>
        <state>Pennsylvania</state>
        <zip>18940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Stern Cardiovascular Foundation</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HeartPlace</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Care Consultants</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79936</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; White Memorial Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart of Dixie Cardiology (formerly Dixie Regional Medical Center - River Road Campus)</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Washington Hospital</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cardiovascular Specialists</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aurora Medical Group</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <state>Limburg</state>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Hospital</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T5H 3V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Boniface General Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R2H 2A6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QE II Health Sciences</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 3A7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston General Hospital</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 2V7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rouge Valley Centenary</name>
      <address>
        <city>Scarborough</city>
        <state>Ontario</state>
        <zip>M1B 4Z8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cardiologie de Montreal (Montreal Heart Inst.)</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäts-Herzzentrum Freiburg - Bad Krozingen</name>
      <address>
        <city>Bad Krozingen</city>
        <zip>79189</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University</name>
      <address>
        <city>Shinjuku-Ku</city>
        <state>Kanto</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Abeno-ku</city>
        <state>Osaka</state>
        <zip>545-8565</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jichi Medical University Hospital</name>
      <address>
        <city>Shimotsuke-shi</city>
        <state>Tochigi-ken</state>
        <zip>329-0498</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mc-Tronik</name>
      <address>
        <city>Lodz</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Maria Hospital</name>
      <address>
        <city>Lisboa</city>
        <state>Lisbon</state>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Germany</country>
    <country>Japan</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 13, 2021</last_update_submitted>
  <last_update_submitted_qc>January 13, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HV Lead</keyword>
  <keyword>ICD</keyword>
  <keyword>CRT-D System</keyword>
  <keyword>Treatment of Heart Failure</keyword>
  <keyword>Treamtent of life-threatening ventricular tachyarrhythmia</keyword>
  <keyword>Optisure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>January 11, 2022</submitted>
    <returned>March 14, 2022</returned>
    <submitted>July 26, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02235545
org study id: 60045220
nct id: NCT02235545
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this post approval study is to characterize the chronic performance of the SJM
      Optisure family of HV leads in patients.
observational model: Case-Only
time perspective: Prospective
measure: Freedom from RV Lead Related Complications
time frame: Date at which all patients have completed their five year follow-up.
measure: Optisure Lead-Related Complication Rates
time frame: Date at which all patients have completed their five year follow-up.
measure: Optisure Lead Related Adverse Events
time frame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of lead electrical dysfunction
time frame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of externalized conductors
time frame: Date at which all patients have completed their five year follow-up.
measure: The annual hazard rate of other visual lead anomalies by each subcategory
time frame: Date at which all patients have completed their five year follow-up.
measure: Prevalence of "other insulation anomalies" in "returned leads
time frame: Date at which all patients have completed their five year follow-up.
measure: Time from externalized conductors to electrical dysfunction
time frame: Date at which all patients have completed their five year follow-up.
measure: Time from other visual lead anomalies by each subcategory to electrical dysfunction
time frame: Date at which all patients have completed their five year follow-up.
measure: Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)
time frame: Date at which all patients have completed their five year follow-up.
measure: Time from externalized conductors to clinical intervention
time frame: Date at which all patients have completed their five year follow-up.
measure: Time from other visual lead anomalies by each subcategory to clinical intervention
time frame: Date at which all patients have completed their five year follow-up.
measure: Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies) to those without lead compromise
time frame: Date at which all patients have completed their five year follow-up.
measure: Comparison of patients with electrical dysfunction to those without electrical dysfunction.
time frame: Date at which all patients have completed their five year follow-up.
arm group label: St. Jude Medical Optisure Lead
description: Patients implanted with St. Jude Medical Optisure Lead
intervention type: Device
intervention name: St. Jude Medical Optisure Lead
description: Patients implanted with St. Jude Medical Optisure Lead
arm group label: St. Jude Medical Optisure Lead
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Grant Kim
role: Study Director
affiliation: Abbott Medical Devices
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country: Belgium
country: Canada
country: Germany
country: Japan
country: Poland
country: Portugal
country: United States
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular
submitted: January 11, 2022
returned: March 14, 2022
submitted: July 26, 2023