<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/NCT04496518</url>
  </required_header>
  <id_info>
    <org_study_id>iATP PAS</org_study_id>
    <nct_id>NCT04496518</nct_id>
  </id_info>
  <brief_title>Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)</brief_title>
  <official_title>Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic</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>
      Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)&#xD;
      to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical&#xD;
      practice, following commercial release of iATP-capable devices.&#xD;
&#xD;
      The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform&#xD;
      (NCT01524276).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The iATP PAS is a global, prospective, observational, multi-site registry study. Patients&#xD;
      enrolled in the iATP PAS will be prospectively followed in the registry until registry&#xD;
      closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).&#xD;
&#xD;
      Patient and device status will be assessed at least annually or as prompted by reportable&#xD;
      adverse events. Remote device data transmissions are recommended to occur at least quarterly.&#xD;
      Primary objective analysis will occur when 241 iATP-treated eligible ventricular episodes in&#xD;
      the fast ventricular tachycardia (FVT) zone have been collected and reviewed by the study&#xD;
      episode review committee (ERC). The total study duration is approximately 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%</measure>
    <time_frame>Approximately 5 years</time_frame>
    <description>Demonstrating success rate of iATP</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To demonstrate the success rate of iATP in the FVT zone is greater than 70%</measure>
    <time_frame>Approximately 5 years</time_frame>
    <description>Demonstrating success rate of iATP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize arrhythmia-related syncope events</measure>
    <time_frame>Approximately 5 years</time_frame>
    <description>characterizing arrhythmia-related syncope events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To characterize unnecessary and inappropriate shocks</measure>
    <time_frame>Approximately 5 years</time_frame>
    <description>characterizing unnecessary and inappropriate shocks</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Ventricular Tachycardia</condition>
  <arm_group>
    <arm_group_label>Patients with ICD/CRT device with iATP programmed on</arm_group_label>
    <description>Patients implanted with an iATP-capable device with iATP on in at least one device detection zone will be enrolled in the iATP PAS. Patients must also be enrolled in the CareLink network for remote monitoring. All patients must have provided signed informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Intrinsic Antitachycardia Pacing (iATP) Therapy</intervention_name>
    <description>iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).</description>
    <arm_group_label>Patients with ICD/CRT device with iATP programmed on</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients providing informed consent to participate prior to or within 30 days of&#xD;
        implant of an iATP-capable cardiac rhythm device with iATP on in at least one zone.&#xD;
        Patients need to be enrolled in Medtronic's CareLink network for remote device monitoring.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient or legally authorized representative provides written authorization and/or&#xD;
             consent per institution and geographical requirements&#xD;
&#xD;
          -  Patient is intended to receive or is implanted with an iATP-capable device with iATP&#xD;
             on in any zone with ventricular ATP therapies programmed.&#xD;
&#xD;
          -  Patient is enrolled in the CareLink network for remote device monitoring&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is, or is expected to be inaccessible for follow-up&#xD;
&#xD;
          -  Patient with exclusion criteria required by local law&#xD;
&#xD;
          -  Patient is currently enrolled in or plans to enroll in any concurrent drug and/or&#xD;
             device study that may confound results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>iATP PAS Study Manager</last_name>
    <phone>1-800-633-8766</phone>
    <email>rs.productsurveillanceregistry@medtronic.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Alaska Heart</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>907-561-3211</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southwest EP</name>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>480-776-6844</phone>
    </contact>
    <investigator>
      <last_name>Drory Tendler, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates of Northeast Arkansas</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72410</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>870-207-3827</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Heart Clinic Arkansas</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205-6202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>501-255-6030</phone>
    </contact>
    <investigator>
      <last_name>Mangaraju Chakka, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chula Vista Cardiac Center</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91910</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>619-934-3260</phone>
    </contact>
    <investigator>
      <last_name>Brett Berman, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Diego Arrhythmia Associates</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>619-297-0014</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>COR Healthcare</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>310-792-5800</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants Medical Group (Van Nuys CA)</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>310-824-3378</phone>
    </contact>
    <investigator>
      <last_name>Isaac Wiener, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiology Associates Medical Group</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>661-904-4503</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Dukes, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Colorado Springs Cardiology</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>719-776-2514</phone>
    </contact>
    <investigator>
      <last_name>Christopher Cole, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Denver Heart</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>303-331-9121</phone>
    </contact>
    <investigator>
      <last_name>Christopher Stees, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Colorado Heart and Vascular, PC</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>303-595-2727</phone>
    </contact>
    <investigator>
      <last_name>Ganesh Venkataraman, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hartford Hospital</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>860-972-1964</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>203-466-8177</phone>
    </contact>
    <investigator>
      <last_name>Rachel Lampert, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clearwater Cardiovascular Consultants</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>727-451-1683</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Solutions</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021-3552</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>954-707-5200</phone>
    </contact>
    <investigator>
      <last_name>Awais Humayun, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baptist Health</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207-8208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>904-271-6343</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute of Northwest Florida</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>850-769-0329</phone>
    </contact>
    <investigator>
      <last_name>Nghia Hoang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heart &amp; Vascular Institute of Florida</name>
      <address>
        <city>Safety Harbor</city>
        <state>Florida</state>
        <zip>34695-6604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>727-512-8047</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Consultants P.A. (Sarasota Memorial Research)</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>941-917-1669</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Deaconess Specialty Physicians</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47710</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>812-490-4505</phone>
    </contact>
    <investigator>
      <last_name>Chandrashekar Kumbar, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Iowa Heart Center (West Des Moines IA)</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>515-235-5089</phone>
    </contact>
    <investigator>
      <last_name>Dwayne Campbell, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160-8500</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>913-588-9679</phone>
    </contact>
    <investigator>
      <last_name>Martin Emert, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>859-301-4729</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Heart Specialists</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>502-891-8656</phone>
    </contact>
    <investigator>
      <last_name>Robert Schwartz, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Our Lady of the Lake Office of Research</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>225-765-7659</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tidal Health Peninsula Regional</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>410-334-2333</phone>
    </contact>
    <investigator>
      <last_name>Steven Hearne, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Associates in Cardiology PA</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910-1265</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>301-681-5700</phone>
    </contact>
    <investigator>
      <last_name>Michael Lincoln, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>617-726-5093</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital (Boston MA)</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115-6110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>617-732-5241</phone>
    </contact>
    <investigator>
      <last_name>Melanie Maytin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sparrow Clinical Research Institute</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>517-364-5732</phone>
    </contact>
    <investigator>
      <last_name>John Ip, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UP Health System - Marquette</name>
      <address>
        <city>Marquette</city>
        <state>Michigan</state>
        <zip>49855-2705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>906-225-3870</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Michigan Heart</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197-8633</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>734-712-8252</phone>
    </contact>
    <investigator>
      <last_name>Jihn Han, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Memorial Health Heart &amp; Vascular Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422-2926</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>763-581-6714</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic (Rochester MN)</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55902-1906</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>507-266-2328</phone>
    </contact>
    <investigator>
      <last_name>Abhishek Deshmukh, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Missouri Cardiovascular Specialists</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201-8023</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>573-256-3094</phone>
    </contact>
    <investigator>
      <last_name>Daniel Pierce, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospital (Columbia MO)</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>573-884-4099</phone>
    </contact>
    <investigator>
      <last_name>Mauricio Sendra, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Lukes Health System</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111-5934</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>816-932-6275</phone>
    </contact>
    <investigator>
      <last_name>Brain Ramza, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>314-454-7422</phone>
    </contact>
    <investigator>
      <last_name>Mitchell Faddis, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nebraska Medicine</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>402-559-4067</phone>
    </contact>
    <investigator>
      <last_name>Shane Tsai, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Monmouth Cardiology Associates</name>
      <address>
        <city>Ocean City</city>
        <state>New Jersey</state>
        <zip>07712-4764</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>732-663-0300</phone>
      <phone_ext>1129</phone_ext>
    </contact>
    <investigator>
      <last_name>L Steven Zukerman, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Presbyterian Heart Group</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106-4921</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>505-563-2716</phone>
    </contact>
    <investigator>
      <last_name>Lawrence Nair, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>South Shore University Hospital</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>631-968-3009</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Huntington Hospital</name>
      <address>
        <city>Huntington</city>
        <state>New York</state>
        <zip>11743</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>631-547-7191</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>631-968-3009</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northern Westchester Hospital</name>
      <address>
        <city>Mount Kisco</city>
        <state>New York</state>
        <zip>10549</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>914-362-6199</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Long Island Jewish Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>516-881-7027</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>New York-Presbyterian Hospital/Weill Cornell Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>212-746-4617</phone>
    </contact>
    <investigator>
      <last_name>Steven Markowitz, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>NewYork-Presbyterian/Columbia University Irving Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>845-866-6426</phone>
    </contact>
    <investigator>
      <last_name>Fredrick Ehlert, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>212-434-3934</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hudson Valley Heart Center</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601-3923</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>845-473-1188</phone>
      <phone_ext>51217</phone_ext>
    </contact>
    <investigator>
      <last_name>Sankar Varanasi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Staten Island University Hospital</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10305-3436</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>718-226-7953</phone>
    </contact>
    <investigator>
      <last_name>Jonathan Willner, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center (DUMC)</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>919-681-8983</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>WakeMed Health &amp; Hospitals</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>919-350-5252</phone>
    </contact>
    <investigator>
      <last_name>Marc Silver, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Summa Center for Clinical Trials-Northeast Ohio Cardiovascular Specialists</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304-1473</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>330-375-6673</phone>
    </contact>
    <investigator>
      <last_name>Michael Pelini, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Christ Hospital Health Network</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>513-585-2159</phone>
    </contact>
    <investigator>
      <last_name>Dean Kereiakes, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267-0542</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>513-558-3415</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>216-444-4959</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Luke's University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015-1000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>484-526-7827</phone>
    </contact>
    <investigator>
      <last_name>Darren Traub, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>570-214-4964</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>UPMC Heart and Vascular Institute at UPMC Hamot</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16507-1579</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>814-877-2082</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Geisinger Wyoming Valley Medical Center</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>570-808-6123</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Saint Thomas Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37205-2018</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>615-222-3870</phone>
    </contact>
    <investigator>
      <last_name>James Baker, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>615-343-8647</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Cardiac Arrhythmia Research Foundation</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705-1852</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>512-522-9410</phone>
    </contact>
    <investigator>
      <last_name>Robert Canby, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heart Center of North Texas</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>761014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>817-334-2800</phone>
    </contact>
    <investigator>
      <last_name>Aleem Mughal, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Consultants in Cardiology (Fort Worth TX)</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>817-250-1950</phone>
    </contact>
    <investigator>
      <last_name>Theodore Takata, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>EP Heart</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>713-486-1637</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Kootenai Heart Clinics Northwest</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99204-2352</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>509-847-2500</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Aurora Cardiovascular Services</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215-3678</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>262-249-5432</phone>
    </contact>
    <investigator>
      <last_name>Jodi Lyn Zilinski, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clinique Rhône Durance</name>
      <address>
        <city>Avignon</city>
        <zip>84082</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>leperchois.jacquey@gmail.com</email>
    </contact>
    <investigator>
      <last_name>François Xavier Hager, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de la Côte Basque</name>
      <address>
        <city>Bayonne</city>
        <zip>64109</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 676309286</phone>
    </contact>
    <investigator>
      <last_name>Julien Laborderie, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 298347151</phone>
    </contact>
    <investigator>
      <last_name>Jacques Mansourati, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Générale de Santé - Hôpital Privé Saint Martin</name>
      <address>
        <city>Caen</city>
        <zip>14000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>c.desmortreux@ramsaygds.fr</email>
    </contact>
    <investigator>
      <last_name>Alain Lebon, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Caen - Hôpital Côte de Nacre - Centre Esquirol</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>rots-d@chu-caen.fr</email>
    </contact>
    <investigator>
      <last_name>Pierre Ollitrault, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand - Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 473754109</phone>
    </contact>
    <investigator>
      <last_name>Romain Eschalier, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Hospital Le Bocage</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>frederique.debomy@chu-dijon.fr</email>
    </contact>
    <investigator>
      <last_name>Géraldine Bertaux, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU La Rochelle</name>
      <address>
        <city>La Rochelle</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 516494165</phone>
    </contact>
    <investigator>
      <last_name>Antoine Milhem, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital prive Clairval - Ramsay Sante</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
    </contact>
    <investigator>
      <last_name>Alexis Mechulan, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nouvelles Cliniques Nantaises</name>
      <address>
        <city>Nantes</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 228255654</phone>
    </contact>
    <investigator>
      <last_name>Daniel Gras, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de la région d'Annecy</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 450636684</phone>
    </contact>
    <investigator>
      <last_name>Antoine Dompnier, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Saint Étienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <zip>42270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 477829081</phone>
    </contact>
    <investigator>
      <last_name>Antoine Da Costa, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Capio - Clinique du Tonkin</name>
      <address>
        <city>Villeurbanne</city>
        <zip>69100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+33 437484805</phone>
    </contact>
    <investigator>
      <last_name>Hervé Poty, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hygeia Hospital</name>
      <address>
        <city>Athens</city>
        <zip>15123</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+30 6972831109</phone>
    </contact>
    <investigator>
      <last_name>Theodoros Apostolopoulos, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Athens Medical Center</name>
      <address>
        <city>Maroúsi</city>
        <zip>15125</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+30 6932279620</phone>
    </contact>
    <investigator>
      <last_name>Dimitrios Tsiachris, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico Sant' Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+39 516363867</phone>
    </contact>
    <investigator>
      <last_name>Igor Diemberger, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Provinciale di Cosenza&quot;Ospedale di Castrovillari&quot;</name>
      <address>
        <city>Castrovillari</city>
        <zip>87012</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>torchiac2017@libero.it</email>
    </contact>
    <investigator>
      <last_name>Giovanni Bisignani, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Vito Fazzi&quot; Lecce</name>
      <address>
        <city>Lecce</city>
        <zip>73100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <email>maulau1971@libero.it</email>
    </contact>
    <investigator>
      <last_name>Ennio Carmine Luigi Pisanò, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera ospedale Niguarada ca Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giuseppe Cattafi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Centrale - SS.Annunziata</name>
      <address>
        <city>Taranto</city>
        <zip>74024</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giovanni Luzzi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaleria Santa Maria dellaMisericordia di Udine</name>
      <address>
        <city>Udine</city>
        <zip>33100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Domenico Facchin, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital da Senhora da Oliveira -Guimarães</name>
      <address>
        <city>Guimarães</city>
        <zip>4835-044</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Víctor Sanfins, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria-Centro HospitalarLisboa Norte, EPE</name>
      <address>
        <city>Lisbon</city>
        <zip>1649-035</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+351 965500663</phone>
    </contact>
    <investigator>
      <last_name>João Manuel Frazão Rodrigues de Sousa, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de SãoJoão Alameda</name>
      <address>
        <city>Porto</city>
        <zip>4200-319</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Adao</last_name>
    </contact>
    <investigator>
      <last_name>Luís Adão, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Distrital de Santarém</name>
      <address>
        <city>Santarém</city>
        <zip>2000-177</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Vitor Martins, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Národný ústav srdcových a cievnych chorôb, a.s. (NUSCH, a.s.)</name>
      <address>
        <city>Bratislava</city>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Michal Sasov, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario da coruna</name>
      <address>
        <city>Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luisa Pérez Álvarez, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves</name>
      <address>
        <city>Granda</city>
        <zip>18014</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pablo Sánchez, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Cecilio</name>
      <address>
        <city>Granda</city>
        <zip>18016</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sebastián Giacomán, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rafael Salguero Bodes, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Javier Jiménez Candil, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>José Luis Martínez Sande, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora de Candelaria</name>
      <address>
        <city>Tenerife</city>
        <zip>38010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luis Álvarez, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <zip>47006</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maria Gracia Sandín, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Geneva</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Coordinator</last_name>
      <phone>+41 223727200</phone>
    </contact>
    <investigator>
      <last_name>Haran Burri, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiopark Zurich</name>
      <address>
        <city>Zürich</city>
        <zip>8027</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eva Buhlmann, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2GW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Francisco Leyva-Leon, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Blackpool, Fylde and Wyre Hospitals NHSFoundation Trust - Blackpool Victoria Hospital</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alison Seed, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liverpool Heart and Chest Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Archana Rao, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zachary Whinnett, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS - mancester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Amir Zaidi, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The James Cook University Hospital - SouthTees Hospitals NHS</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nicholas John Linker, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheffield Vascular Institute, Sheffield TeachingHospitals NHS - Northern Genera</name>
      <address>
        <city>Sheffield</city>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nigel Lewis, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
    <country>Greece</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tachycardia</mesh_term>
    <mesh_term>Tachycardia, Ventricular</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496518
org study id: iATP PAS
nct id: NCT04496518
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
Medtronic is sponsoring the Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS)
      to further confirm safety and effectiveness of ventricular iATP therapy in routine clinical
      practice, following commercial release of iATP-capable devices.

      The iATP PAS is conducted within Medtronic's Product Surveillance Registry platform
      (NCT01524276).
The iATP PAS is a global, prospective, observational, multi-site registry study. Patients
      enrolled in the iATP PAS will be prospectively followed in the registry until registry
      closure, patient death, or patient exit from the registry (i.e., withdrawal of consent).

      Patient and device status will be assessed at least annually or as prompted by reportable
      adverse events. Remote device data transmissions are recommended to occur at least quarterly.
      Primary objective analysis will occur when 241 iATP-treated eligible ventricular episodes in
      the fast ventricular tachycardia (FVT) zone have been collected and reviewed by the study
      episode review committee (ERC). The total study duration is approximately 5 years.
observational model: Cohort
time perspective: Prospective
measure: To demonstrate the success rate of iATP in the fast VT (FVT) zone is greater than 60%
time frame: Approximately 5 years
description: Demonstrating success rate of iATP
measure: To demonstrate the success rate of iATP in the FVT zone is greater than 70%
time frame: Approximately 5 years
description: Demonstrating success rate of iATP
measure: To characterize arrhythmia-related syncope events
time frame: Approximately 5 years
description: characterizing arrhythmia-related syncope events
measure: To characterize unnecessary and inappropriate shocks
time frame: Approximately 5 years
description: characterizing unnecessary and inappropriate shocks
arm group label: Patients with ICD/CRT device with iATP programmed on
description: Patients implanted with an iATP-capable device with iATP on in at least one device detection zone will be enrolled in the iATP PAS. Patients must also be enrolled in the CareLink network for remote monitoring. All patients must have provided signed informed consent.
intervention type: Device
intervention name: Intrinsic Antitachycardia Pacing (iATP) Therapy
description: iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
arm group label: Patients with ICD/CRT device with iATP programmed on
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: iATP PAS Study Manager
phone: 1-800-633-8766
email: rs.productsurveillanceregistry@medtronic.com
facility: 
status: Not yet recruiting
contact: 
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contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: France
country: Greece
country: Italy
country: Portugal
country: Slovakia
country: Spain
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Tachycardia
mesh term: Tachycardia, Ventricular