<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/NCT01722188</url>
  </required_header>
  <id_info>
    <org_study_id>CD0196</org_study_id>
    <nct_id>NCT01722188</nct_id>
  </id_info>
  <brief_title>Lead Registry for Optim Leads</brief_title>
  <acronym>OPTIMUM</acronym>
  <official_title>Optim Lead Insulation Material Registry</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multi-center, actively monitored, long term data collection registry.&#xD;
      Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a&#xD;
      compatible market released cardia rhythm management (CRM) implantable pulse generator is&#xD;
      eligible for enrollment into the registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients are enrolled in the registry up to 180 days post implantation of an Optim lead.&#xD;
      Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are&#xD;
      followed indefinitely following enrollment. Patients with other Optim leads are followed for&#xD;
      a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is&#xD;
      based on the established follow-up practices currently used by each of the respective&#xD;
      registry centers. Patients are followed according to the center's standard follow-up&#xD;
      schedule.&#xD;
&#xD;
      At each office/clinic follow-up visit standard electrical measurements are collected. During&#xD;
      system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex®&#xD;
      µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or&#xD;
      the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy&#xD;
      or chest X-ray is performed according to the site's standard of care then copies of those&#xD;
      should be submitted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2006</start_date>
  <completion_date type="Actual">July 2020</completion_date>
  <primary_completion_date type="Actual">July 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>Survival from insulation related adverse events</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">14124</enrollment>
  <condition>Optim Lead Insulation Related Adverse Events</condition>
  <arm_group>
    <arm_group_label>Optim Leads</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients implanted with market released SJM Optim lead and a compatible market released CRM&#xD;
        implantable pulse generator (pacemaker, implantable cardioverter defibrillator (ICD), or&#xD;
        cardiac resynchronization therapy device (CRT)) is eligible for enrollment into the&#xD;
        registry.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has a standard indication for a CRM implantable pulse generator.&#xD;
&#xD;
          -  Patient receives a market released SJM Optim lead at implant.&#xD;
&#xD;
          -  Patient receives a market released CRM implantable pulse generator at implant.&#xD;
&#xD;
          -  Patient is willing to provide authorization for registry participation.&#xD;
&#xD;
          -  Complete device implant information, including any Optim lead related adverse event is&#xD;
             available&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has medical conditions or related factors that would prevent or limit&#xD;
             participation (including mechanical tricuspid valves, tricuspid valvular disease, and&#xD;
             candidacy for heart transplants within 6 months).&#xD;
&#xD;
          -  Patient is &lt; 18 years of age.&#xD;
&#xD;
          -  Patient has a life expectancy of &lt; 2 years (malignancies)&#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>Heart South Cardiovascular Group PC</name>
      <address>
        <city>Alabaster</city>
        <state>Alabama</state>
        <zip>35007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Appalachian Cardiovascular Associates</name>
      <address>
        <city>Fort Payne</city>
        <state>Alabama</state>
        <zip>35968</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Alabama Cardiology Center</name>
      <address>
        <city>Gadsden</city>
        <state>Alabama</state>
        <zip>35903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Mobile, Inc.</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Heart Institute</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pima Heart Physicians, PC</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Arizona VA Health Care System</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Cardiology</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>*Little Rock Cardiology Clinic</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cardiology</name>
      <address>
        <city>Springdale</city>
        <state>Arkansas</state>
        <zip>72764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westside Cardiovascular Associates</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</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>Mills-Peninsula Cardiovascular Specialists</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Interventional Cardiology and Nephrology</name>
      <address>
        <city>Encino</city>
        <state>California</state>
        <zip>91436</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Institute</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid Valley Cardiology</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Care Specialists</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glendale Memorial Hospital and Medical Center</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apex Cardiology</name>
      <address>
        <city>Inglewood</city>
        <state>California</state>
        <zip>90301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kartik Thaker, MD Inc.</name>
      <address>
        <city>Lakewood</city>
        <state>California</state>
        <zip>90712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omid Vahdat M.D.</name>
      <address>
        <city>Los Alamitos</city>
        <state>California</state>
        <zip>90720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donna Gallik MD</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeffrey Goodman MD</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Payam Yashar M.D.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stephen S. Ehrlich, MD</name>
      <address>
        <city>Mission Viejo</city>
        <state>California</state>
        <zip>92691</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Valley Cardiovascular Center</name>
      <address>
        <city>Murrieta</city>
        <state>California</state>
        <zip>95263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mehrdad Ariani MD</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soltera Yasuda &amp; Associates</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cabrillo Cardiology Medical Group</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alejandro Garcia MD</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Desert Heart Physicians</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California Heart Specialists</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>William A Stellar, MD</name>
      <address>
        <city>Rancho Mirage</city>
        <state>California</state>
        <zip>92270</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>Heart Center of Riverside</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Group Cardiology</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Salinas Valley Memorial Hospital</name>
      <address>
        <city>Salinas</city>
        <state>California</state>
        <zip>93901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bruce A. Ourieff MD</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun City Cardiology Medical Center, Incorporated</name>
      <address>
        <city>Sun City</city>
        <state>California</state>
        <zip>92586</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun City Cardiology Medical Center, Inc</name>
      <address>
        <city>Sun City</city>
        <state>California</state>
        <zip>92586</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael Burnam, MD</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richard P. Cain, MD</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COR Healthcare Medical Associates</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arash Vahdat, MD</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shiva Heart Center Medical Group</name>
      <address>
        <city>Wildomar</city>
        <state>California</state>
        <zip>92595</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Feather River Cardiovascular Institute</name>
      <address>
        <city>Yuba City</city>
        <state>California</state>
        <zip>95991</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yuba Sutter Medical Clinic</name>
      <address>
        <city>Yuba City</city>
        <state>California</state>
        <zip>95991</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose St. Francis Cardiology Associates PC</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pikes Peak Cardiology</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harvard Park Medical</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Denver Cardiology Associates PC</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grove Hill Medical Center</name>
      <address>
        <city>New Britain</city>
        <state>Connecticut</state>
        <zip>06052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Fairfield County, PC</name>
      <address>
        <city>Norwalk</city>
        <state>Connecticut</state>
        <zip>06851</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Arrhythmia Services</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradenton Heart Center</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Cardiology Associates PA</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cardiology Group</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pinellas Arrhythmia Associates</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okaloosa Heart and Vascular</name>
      <address>
        <city>Crestview</city>
        <state>Florida</state>
        <zip>32539</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Consultants PA</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiology Center, Incorporated</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>White-Wilson Medical Center - Fort Walton Beach</name>
      <address>
        <city>Fort Walton Beach</city>
        <state>Florida</state>
        <zip>32547</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiac &amp; Vascular Institute Research Foundation, LLC</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shands at the University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Institute For Cardiovascular Care</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</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>Clark &amp; Daughtrey Medical Group, PA</name>
      <address>
        <city>Lakeland</city>
        <state>Florida</state>
        <zip>33806-2098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic and Interventional Cardiology</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Melbourne Internal Medicine Associates</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami International Cardiology Consultants Inc</name>
      <address>
        <city>Miami Beach</city>
        <state>Florida</state>
        <zip>33140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Cardiovascular Research LLC</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ram Vasudevan, MD, FACC</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Florida Heart Center</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34474</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Interventions, P.A.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Florida Cardiology Specialist</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Research Associates</name>
      <address>
        <city>Ormond Beach</city>
        <state>Florida</state>
        <zip>32174</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardio Care Center</name>
      <address>
        <city>Palatka</city>
        <state>Florida</state>
        <zip>32177</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Augustine Cardiology Associates</name>
      <address>
        <city>Saint Augustine</city>
        <state>Florida</state>
        <zip>32086</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Care Research</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Heart Center</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarasota Arrhythmia Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Kalpesh Solanki</name>
      <address>
        <city>Summerfield</city>
        <state>Florida</state>
        <zip>34491</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazhar Majid, M.D.</name>
      <address>
        <city>Tamarac</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart &amp; Vascular Center of Venice</name>
      <address>
        <city>Venice</city>
        <state>Florida</state>
        <zip>34292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Athens Heart Center</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Athens Regional Medical Center</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Heart Institute - Buckhead Location</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Heart Foundation</name>
      <address>
        <city>Gainesville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gwinnet Consultants in Cardiology</name>
      <address>
        <city>Lawrenceville</city>
        <state>Georgia</state>
        <zip>30045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kennestone Heart Physicians</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harbin Clinic Southeastern Cardiovascular Institute</name>
      <address>
        <city>Rome</city>
        <state>Georgia</state>
        <zip>30165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Georgia Cardiology PC</name>
      <address>
        <city>Valdosta</city>
        <state>Georgia</state>
        <zip>31602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fox Valley Cardiovascular Consultants</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Provena Saint Joseph Hospital</name>
      <address>
        <city>Elgin</city>
        <state>Illinois</state>
        <zip>60123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MidAmerica Cardiovascular Consultants</name>
      <address>
        <city>Oak Lawn</city>
        <state>Illinois</state>
        <zip>60453</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>Ohio Valley Heart Care</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Margaret Mercy Healthcare Centers</name>
      <address>
        <city>Hammond</city>
        <state>Indiana</state>
        <zip>46320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>River Cities Cardiology</name>
      <address>
        <city>Jeffersonville</city>
        <state>Indiana</state>
        <zip>47130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Consultants</name>
      <address>
        <city>Muncie</city>
        <state>Indiana</state>
        <zip>47303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of NW Indiana</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>46321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unitypoint</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cumberland Cardiology</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bluegrass Cardiology</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health Medical Group, Inc.</name>
      <address>
        <city>Madisonville</city>
        <state>Kentucky</state>
        <zip>42431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandria Cardiology Clinic</name>
      <address>
        <city>Alexandria</city>
        <state>Louisiana</state>
        <zip>71301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freedman Memorial Cardiology</name>
      <address>
        <city>Alexandria</city>
        <state>Louisiana</state>
        <zip>71301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of the Lake Hospital</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Covington Cardiovascular Care</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Tammany Heart and Vascular</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart and Vascular Institute of LA LLC</name>
      <address>
        <city>Lacombe</city>
        <state>Louisiana</state>
        <zip>70445</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mike Mounir MD</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Specialists of SWLA</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial Health, LLP</name>
      <address>
        <city>Lake Charles</city>
        <state>Louisiana</state>
        <zip>70601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Center</name>
      <address>
        <city>Marrero</city>
        <state>Louisiana</state>
        <zip>70072</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gregory C. Sampognaro Interventional Cardiology</name>
      <address>
        <city>Monroe</city>
        <state>Louisiana</state>
        <zip>71201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Incorporated</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eastern Maine Medical Center</name>
      <address>
        <city>Bangor</city>
        <state>Maine</state>
        <zip>04401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Naval Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20889</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Associates PC</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmarva Heart</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peninsula Cardiology Associates, P.A.</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alan Schneider</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Practice</name>
      <address>
        <city>Florence</city>
        <state>Massachusetts</state>
        <zip>01062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiovascular Specialists</name>
      <address>
        <city>Hyannis</city>
        <state>Massachusetts</state>
        <zip>02601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fallon Clinic</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Specialists of Central Massachusetts, PC</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Massachusetts Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology and Arrhythmia Consultants P.C.</name>
      <address>
        <city>Birmingham</city>
        <state>Michigan</state>
        <zip>48009</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regional Cardiology Associates, PLC</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Cardiology Associates</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48307</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Cardiology Consultants</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Traverse Heart Associates</name>
      <address>
        <city>Traverse City</city>
        <state>Michigan</state>
        <zip>49684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lingareddy Devireddy, PC</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Cardiology Associates</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Medical Center Minneapolis</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota Medical Center Fairview</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coast Cardiovascular Consultants</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39532</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coast Cardiology Center</name>
      <address>
        <city>Gulfport</city>
        <state>Mississippi</state>
        <zip>39503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants of Cape Girardeau Inc</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Care Group</name>
      <address>
        <city>Florissant</city>
        <state>Missouri</state>
        <zip>63031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants (now St. Luke's)</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>County Cardiology, Inc.</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141-6835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Cardiology Consultants</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63146</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Physicians Clinic-Heart Consultants</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Creighton Health</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nevada Cardiology Associates</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cooper University Hospital</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Jersey Heart Group</name>
      <address>
        <city>Cherry Hill</city>
        <state>New Jersey</state>
        <zip>08002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hunterdon Cardiovascular Associates</name>
      <address>
        <city>Flemington</city>
        <state>New Jersey</state>
        <zip>08822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Cardiology Associates</name>
      <address>
        <city>Hamilton</city>
        <state>New Jersey</state>
        <zip>08690</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atlantic Health System - Morristown Memorial Hospital</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monmouth Cardiology Associates, LLC</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Consultants of North Jersey</name>
      <address>
        <city>Wayne</city>
        <state>New Jersey</state>
        <zip>07470</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Jersey Cardiology Associates</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Heart Institute</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adirondack Cardiology Associates</name>
      <address>
        <city>Glens Falls</city>
        <state>New York</state>
        <zip>12801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Island Heart Associates</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Arrhythmia and Pacemaker Center</name>
      <address>
        <city>Roslyn</city>
        <state>New York</state>
        <zip>11576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne Heart Internal Medicine</name>
      <address>
        <city>Goldsboro</city>
        <state>North Carolina</state>
        <zip>27534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Cardiology Associates</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <zip>28602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Heart Associates</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Research</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altru Clinic - Main</name>
      <address>
        <city>Grand Forks</city>
        <state>North Dakota</state>
        <zip>58201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Cardiology Associates</name>
      <address>
        <city>Barberton</city>
        <state>Ohio</state>
        <zip>44203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Electrophysiology &amp; Pacing Interventionalists</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Electrophysiology and Pacing Interventionalists</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43222</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Elyria Medical Center</name>
      <address>
        <city>Elyria</city>
        <state>Ohio</state>
        <zip>44035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Fairfield</name>
      <address>
        <city>Fairfield</city>
        <state>Ohio</state>
        <zip>45014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Institute Of Cardiac Care</name>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Care Cardiology Consultants, Inc.</name>
      <address>
        <city>Steubenville</city>
        <state>Ohio</state>
        <zip>43952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Medical of Ohio</name>
      <address>
        <city>Steubenville</city>
        <state>Ohio</state>
        <zip>43952</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Ohio Cardiology Consultants</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio Heart Institute</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Arrhythmia Associates</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khastgir, Terrance M.D.</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants, Inc.</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abington Medical Specialists</name>
      <address>
        <city>Abington</city>
        <state>Pennsylvania</state>
        <zip>19001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SouthWestern Pennsylvania Cardiovascular Associates</name>
      <address>
        <city>Butler</city>
        <state>Pennsylvania</state>
        <zip>16001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dubois Regional Cardiology Associates</name>
      <address>
        <city>Sandy</city>
        <state>Pennsylvania</state>
        <zip>15801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Donald Guthrie Foundation for Education and Research</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charleston Cardiology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Cardiology</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Carolina Heart Center</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pee Dee Cardiology Associates, PA</name>
      <address>
        <city>Florence</city>
        <state>South Carolina</state>
        <zip>29506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Piedmont Cardiology</name>
      <address>
        <city>Greenwood</city>
        <state>South Carolina</state>
        <zip>29646</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chattanooga Heart Institute</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain States Medical Group Cardiology</name>
      <address>
        <city>Johnson City</city>
        <state>Tennessee</state>
        <zip>37601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Tennessee Heart Consultants - Knoxville</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Knoxville Cardiovascular Research Group, LLC</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arrhythmia Consultants, P.C.</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Consultants</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay City Cardiology Clinic at Matagorda General Hospital</name>
      <address>
        <city>Bay City</city>
        <state>Texas</state>
        <zip>77404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Texas Cardiology</name>
      <address>
        <city>Beaumont</city>
        <state>Texas</state>
        <zip>77702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BCS Heart, LLP</name>
      <address>
        <city>College Station</city>
        <state>Texas</state>
        <zip>77845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dallas Heart Group</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Texas Heart Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75231-3833</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center at Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390-9016</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>Texas Heart Clinic, PA</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Cardiac Arrhythmias</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EP/Cardiology PA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willowbrook Cardiovascular Associates</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Association, P.L.L.C.</name>
      <address>
        <city>Humble</city>
        <state>Texas</state>
        <zip>77338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Permian Cardiology Associates</name>
      <address>
        <city>Midland</city>
        <state>Texas</state>
        <zip>79761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odessa Heart Institute, P. A.</name>
      <address>
        <city>Odessa</city>
        <state>Texas</state>
        <zip>79761</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miguel E. Castellanos, MD</name>
      <address>
        <city>Orange</city>
        <state>Texas</state>
        <zip>77630</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Texas Cardiovascular Consultants</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Clinic Of San Antonio Pa</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center, Division of Cardiology</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78234</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>Cardiovascular Associates of East Texas</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria Heart and Vascular</name>
      <address>
        <city>Victoria</city>
        <state>Texas</state>
        <zip>77901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Associates Ltd</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiovascular Group</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Riverside Heart Specialists</name>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <zip>23666</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrisonburg Medical Associations, Inc.</name>
      <address>
        <city>Harrisonburg</city>
        <state>Virginia</state>
        <zip>22801</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>Hunter Holmes McGuire VAMC</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23249</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bellevue Cardiology</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlake Internal Medicine Associates</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kitsap Cardiology Consultants</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Skagit Valley Medical Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Washington</state>
        <zip>98274</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Institute at Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sacred Heart Medical Center</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Heart Clinics</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Cardiology Associates</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Heart &amp; Vascular Associates</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Green Bay, Ltd.</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301-3528</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dean Foundation</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Hospital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Irtel von Brenndorff</name>
      <address>
        <city>Baden-Baden</city>
        <state>Bad-wur</state>
        <zip>76532</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Markert</name>
      <address>
        <city>Gaggenau</city>
        <state>Bad-wur</state>
        <zip>76571</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Behroz</name>
      <address>
        <city>Heidelberg</city>
        <state>Bad-wur</state>
        <zip>69123</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Thomas Fadgyas</name>
      <address>
        <city>Dortmund</city>
        <state>N. Rhin</state>
        <zip>44137</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Bernhardt</name>
      <address>
        <city>Annaberg-Buchholz</city>
        <state>Saxony</state>
        <zip>9456</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. Med. Stellmach</name>
      <address>
        <city>Chemnitz</city>
        <state>Saxony</state>
        <zip>09126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Frau Dr. med. Strucks</name>
      <address>
        <city>Nossen</city>
        <state>Saxony</state>
        <zip>01683</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Pirna GmbH Klinik für Innere Medizin II</name>
      <address>
        <city>Pirna</city>
        <state>Saxony</state>
        <zip>1796</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kreiskrankenhaus des Bördekreises Krankenhaus 4</name>
      <address>
        <city>Oschersleben</city>
        <state>Sxnyanh</state>
        <zip>39387</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang</name>
      <address>
        <city>Erfurt</city>
        <state>Thurgia</state>
        <zip>99084</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helios-Klinikum Erfurt GmbH</name>
      <address>
        <city>Erfurt</city>
        <state>Thurgia</state>
        <zip>99089</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik St. Georg</name>
      <address>
        <city>Hamberg</city>
        <zip>20099</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Nord Heidberg-Ochsenzoll</name>
      <address>
        <city>Hamberg</city>
        <zip>22417</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Altona</name>
      <address>
        <city>Hamberg</city>
        <zip>22763</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Subin</name>
      <address>
        <city>Hamburg</city>
        <zip>20095</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>May 7, 2021</last_update_submitted>
  <last_update_submitted_qc>May 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Optim</keyword>
  <keyword>Insulation</keyword>
  <!-- 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/NCT01722188
org study id: CD0196
nct id: NCT01722188
lead sponsor: 
has dmc: No
This is a prospective, multi-center, actively monitored, long term data collection registry.
      Any Patient that receives a market released St. Jude Medical (SJM) Optim lead and a
      compatible market released cardia rhythm management (CRM) implantable pulse generator is
      eligible for enrollment into the registry.
Patients are enrolled in the registry up to 180 days post implantation of an Optim lead.
      Patients with Optim™ ICD leads and Quicksite®/Quickflex®/Quickflex® µ/Quartet® LV leads are
      followed indefinitely following enrollment. Patients with other Optim leads are followed for
      a period of 60 months after Optim™ lead implantation. The follow-up plan for this registry is
      based on the established follow-up practices currently used by each of the respective
      registry centers. Patients are followed according to the center's standard follow-up
      schedule.

      At each office/clinic follow-up visit standard electrical measurements are collected. During
      system revision in a patient with either Optim™ ICD leads, Quicksite®, Quickflex®, Quickflex®
      µ or Quartet® LV lead, cinefluoroscopy (AP, LAO 45° or the best possible LAO view, RAO 45° or
      the best possible RAO view) should be performed at specific study sites. If cinefluoroscopy
      or chest X-ray is performed according to the site's standard of care then copies of those
      should be submitted.
observational model: Case-Only
time perspective: Prospective
measure: Survival from insulation related adverse events
time frame: 5 years
arm group label: Optim Leads
study pop: 
sampling method: 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: Germany
country: United States
responsible party type: Sponsor