<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/NCT04489225</url>
  </required_header>
  <id_info>
    <org_study_id>HFRS PAS</org_study_id>
    <nct_id>NCT04489225</nct_id>
  </id_info>
  <brief_title>Personalized Therapy Study - HFRS (TriageHF) Post Approval Study</brief_title>
  <official_title>Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in&#xD;
      routine clinical practice following commercial release. The HFRS PAS is conducted within&#xD;
      Medtronic's Product Surveillance Registry (PSR) platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted&#xD;
      with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead&#xD;
      (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will&#xD;
      be followed per the standard of care practices of their care provider.&#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</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>
  <primary_outcome>
    <measure>positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of HF hospitalization or HF related deaths</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2200</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Observational</arm_group_label>
    <description>This single arm observational study includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR). Patients will be followed per the standard of care practices of their care provider. All patients must provide a signed informed consent.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Observational only without any intervention</description>
    <arm_group_label>Observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes all patients implanted with a Medtronic Cobalt™ XT ICD or&#xD;
        CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who&#xD;
        are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry&#xD;
        (PSR).&#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 has or is intended to receive or be treated with an eligible ICD or CRT device&#xD;
             or Patients may be enrolled pre-implant and up to 30 days post-implant following&#xD;
             confirmation of patient eligibility.&#xD;
&#xD;
          -  Patient is enrolled in the Medtronic CareLink® Network for remote 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>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>PSR Study Team</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>99508-4673</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
    <contact_backup>
      <phone>(907) 561-3211</phone>
    </contact_backup>
  </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>Study 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>72410-4163</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>Study 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>92103-2120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study 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>Study Coordinator</last_name>
      <phone>310-792-5800</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants Medical Group</name>
      <address>
        <city>Van Nuys</city>
        <state>California</state>
        <zip>91405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>818-782-5041</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>93003-2840</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>818-309-5542</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>Study 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>80220-3918</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>06102-8000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>860-545-1506</phone>
    </contact>
    <investigator>
      <last_name>Steve Zweibel, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Study 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>33756-3356</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
    </contact>
    <contact_backup>
      <phone>(727) 451-1683</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Solutions</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Primary 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</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>904-271-6343</phone>
    </contact>
    <investigator>
      <last_name>Venkata Sagi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>Study 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>Study 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>Study Coordinator</last_name>
      <phone>941-917-1669</phone>
    </contact>
    <investigator>
      <last_name>Antonio Moretta, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Deaconess Specialty Physicians</name>
      <address>
        <city>Evansville</city>
        <state>Indiana</state>
        <zip>47710-1658</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>515-633-3600</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>Study Coordinator</last_name>
      <phone>913-588-5000</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>41017-3439</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study 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>40205-3373</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>502-891-8640</phone>
      <phone_ext>12520</phone_ext>
    </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>Study Coordinator</last_name>
      <phone>225-765-7659</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>TidalHealth Peninsula Regional, Inc.</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>02114-2621</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>617-726-5093</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Brigham and Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>Study Coordinator</last_name>
      <phone>906-449-3440</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>Study 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 Heart and Vascular Institute</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>763-581-6714</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>507-284-2511</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>Study 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 of Missouri</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>573-884-4099</phone>
    </contact>
    <investigator>
      <last_name>Richard Weachter, 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>Study Coordinator</last_name>
      <phone>816-932-6275</phone>
    </contact>
    <investigator>
      <last_name>Brian 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>Study 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>Study Coordinator</last_name>
      <phone>402-559-8862</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>Eatontown</city>
        <state>New Jersey</state>
        <zip>07724</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>732-663-0300</phone>
    </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>Study 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>Study 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>Study Coordinator</last_name>
      <phone>845-866-6426</phone>
    </contact>
    <investigator>
      <last_name>Frederick 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>Study 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</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>Study 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>Study 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>Study 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>Study 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>Study Coordinator</last_name>
      <phone>513-558-3415</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195-0001</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study Coordinator</last_name>
      <phone>216-444-4959</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>St Lukes University Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>Study Coordinator</last_name>
      <phone>814-877-3395</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>Study 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>Study 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>37232-8802</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study 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>Study 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>Consultants in Cardiology</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104-2821</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>Heart Center of North Texas</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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>EP Heart</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77384-4103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Study 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>Study 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</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Study 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 Rhone Durance</name>
      <address>
        <city>Avignon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Francious 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>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Julien Laborderie, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jacques Mansourati</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>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pierre Ollitrault, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Générale de Santé - Hôpital Privé Saint Martin</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alain Lebon, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Romain Eschalier, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Hospital Le Bocage</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Geraldine Bertaux, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHRU La Rochelle</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Antoine Milhem, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital prive Clairval - Ramsay Sante</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Alexis Mechulan, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch de La Region D'Annecy</name>
      <address>
        <city>Metz-Tessy</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Antoine Dompnier, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nouvelles Cliniques Nantaises</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniel Gras, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chu Nord Saint-Étienne</name>
      <address>
        <city>Saint-Priest-en-Jarez</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Antoine De Costa, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Capio - Clinique du Tonkin</name>
      <address>
        <city>Villeurbanne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Herve' Poty, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hygeia Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Theodoros D Apostolopoulos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Athens Medical Center</name>
      <address>
        <city>Maroúsi</city>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dimitrios Tsiachris, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Policlinico Sant' Orsola - Malpighi</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Igor Diemberger, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Provinciale di Cosenza &quot;Ospedale di Castrovillari&quot;</name>
      <address>
        <city>Cosenza</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giovanni Bisignani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale &quot;Vito Fazzi&quot; Lecce</name>
      <address>
        <city>Lecce</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ennio Carmine Luigi Pisanò, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Ca Granda</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Guiseppe Cattafi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Presidio Ospedaliero Centrale - SS. Annunziata</name>
      <address>
        <city>Taranto</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giovanni Luzzi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda ospedaleria Santa Maria della Misericordia di Udine</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Domenico Facchin, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital da Senhora da Oliveira - Guimarães</name>
      <address>
        <city>Guimarães</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Victor Sanfins, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria-Centro Hospitalar Lisboa Norte, EPE</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>João de Sousa, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar Universitário de São João</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luís Adão, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Distrital de Santarém</name>
      <address>
        <city>Santarém</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Vitor Martins, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Národný ústav srdcových a cievnych chorôb, a.s. (NÚSCH, 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 Coruña</name>
      <address>
        <city>Coruña</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luisa Perez Alvarez, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Cecilio</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sebastián Giacomán, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen de las Nieves</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pablo Sánchez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rafael Salguero Bodes, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Javier Jiménez Candil, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jose Luis Martinez Sande, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora de Candelaria</name>
      <address>
        <city>Tenerife</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luis Alvarez, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valladolid</name>
      <address>
        <city>Valladolid</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maria Sandin, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Genève</name>
      <address>
        <city>Geneve</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Haran Burri, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiopark Zurich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Eva Bühlmann, M.D.</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>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Francisco L Leon</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Blackpool, Fylde and Wyre Hospitals NHS Foundation Trust - Blackpool Victoria Hospital</name>
      <address>
        <city>Blackpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alison Seed, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Liverpool Heart and Chest Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Archana Rao, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust - Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zachary Whinnett, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS - Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Amir Zaidi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The James Cook University Hospital - South Tees Hospitals NHS</name>
      <address>
        <city>Middlesbrough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nicholas J Linker, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS - Northern General</name>
      <address>
        <city>Sheffield</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lewis Nigel, MD</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 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 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>Heart Failure</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/NCT04489225
org study id: HFRS PAS
nct id: NCT04489225
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in
      routine clinical practice following commercial release. The HFRS PAS is conducted within
      Medtronic's Product Surveillance Registry (PSR) platform.
The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted
      with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead
      (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will
      be followed per the standard of care practices of their care provider.
observational model: Cohort
time perspective: Prospective
measure: positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
time frame: Up to 5 years
description: To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
measure: Number of HF hospitalization or HF related deaths
time frame: Up to 5 years
description: Summarize the number of HF hospitalization or HF related deaths that were not preceded by a High-Risk Status.
arm group label: Observational
description: This single arm observational study includes all patients implanted with a Medtronic Cobalt™ XT ICD or CRT-D MRI SureScan™ (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)), who are enrolled in the Medtronic CareLink (CL) Network and Product Surveillance Registry (PSR). Patients will be followed per the standard of care practices of their care provider. All patients must provide a signed informed consent.
intervention type: Other
intervention name: Observational
description: Observational only without any intervention
arm group label: Observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: PSR Study Team
phone: 1-800-633-8766
email: rs.productsurveillanceregistry@medtronic.com
facility: 
status: Not yet recruiting
contact: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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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: Heart Failure