<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/NCT03232944</url>
  </required_header>
  <id_info>
    <org_study_id>MPP PAS</org_study_id>
    <nct_id>NCT03232944</nct_id>
  </id_info>
  <brief_title>Personalized CRT - MPP Post Approval Study</brief_title>
  <official_title>Personalized CRT - Multiple Point Pacing 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to&#xD;
      improve CRT response in the non-responder patient population when used in &quot;real-world&quot;&#xD;
      clinical practice, following commercial release. This evaluation is based on the Clinical&#xD;
      Composite Score which summarizes the proportions and frequencies of CRT non-responder&#xD;
      patients who are &quot;improved&quot;, &quot;unchanged&quot; or &quot;worsened&quot; after receiving MPP therapy. Patients&#xD;
      will be followed for the duration of the PAS. This study is required by FDA as a condition of&#xD;
      approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems&#xD;
      approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to&#xD;
      contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities&#xD;
      receiving appropriate license or regulatory approval during the conduct of the PAS were&#xD;
      included and contributed to the PAS objectives upon commercial release. CRT is an established&#xD;
      pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized&#xD;
      biventricular (BiV) pacing using standard pacing technology combined with a special third&#xD;
      lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense&#xD;
      and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced&#xD;
      event, both ventricles are stimulated to synchronize their contraction. The MPP feature is&#xD;
      designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV&#xD;
      Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as&#xD;
      applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either&#xD;
      before or after the LV paces, with the order determined by the programmed Ventricular Pacing&#xD;
      Configuration.&#xD;
&#xD;
      The MPP PAS was a global, prospective, observational multi-center study. Patients implanted&#xD;
      with an eligible CRT Quad system were enrolled and followed in the Product Surveillance&#xD;
      Registry per the expected standard of care practices of their care provider.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 5, 2017</start_date>
  <completion_date type="Actual">January 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 4, 2020</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>3 Years</target_duration>
  <primary_outcome>
    <measure>MPP therapy responder</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed &quot;on&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HF hospitalization and/or mortality</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1338</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>CRT non-responders with MPP enabled</arm_group_label>
    <description>Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization Therapy - MPP</intervention_name>
    <description>The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.</description>
    <arm_group_label>CRT non-responders with MPP enabled</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes patients that are or will be implanted with an eligible CRT&#xD;
        Quad system.&#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 CRT device&#xD;
&#xD;
          -  Patient within 30 days of therapy received at the time of their initial PSR platform&#xD;
             enrollment&#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>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Desert Heart Rhythm Consultants</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COR Healthcare</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Denver Heart</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80204</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Heart Rhythm Solutions</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist Health</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Phoebe Putney Memorial Hospital</name>
      <address>
        <city>Albany</city>
        <state>Georgia</state>
        <zip>31701</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>MedStar Health Research Institute</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237-3958</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Johns Hopkins Hospital</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmarva Heart Research Foundation Inc</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804-6938</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Michigan Heart</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197-8633</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis Heart Institute Foundation</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407-1157</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>HealthCare Partners Medical Group</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052-4171</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian Heart Group</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87106-4921</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Island Cardiac Specialists</name>
      <address>
        <city>Garden City</city>
        <state>New York</state>
        <zip>11530-1613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Hospital</name>
      <address>
        <city>Huntington</city>
        <state>New York</state>
        <zip>11743-2787</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Central New York Cardiology</name>
      <address>
        <city>Utica</city>
        <state>New York</state>
        <zip>13501-5930</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Northeast Ohio Cardiovascular Specialists</name>
      <address>
        <city>Akron</city>
        <state>Ohio</state>
        <zip>44304-1473</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>Mercy Health - Saint Vincent Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Oklahoma</state>
        <zip>44195-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Health Network</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103-6381</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </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>
  </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>
  </location>
  <location>
    <facility>
      <name>The University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Aurora Cardiovascular Services</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven - Campus Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Mont-Godinne - Dinant</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de cardiologie et de pneumologie de Québec (IUCPQ)</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Brest - Hôpital de la Cavale Blanche</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU La Rochelle</name>
      <address>
        <city>La Rochelle</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Montpellier - Hôpital Arnaud de Villeneuve</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nouvelles Cliniques Nantaises</name>
      <address>
        <city>Nantes</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre hospitalier de la région d'Annecy</name>
      <address>
        <city>Pringy</city>
        <zip>74374</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Aachen, AöR</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>045147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum des Saarlandes</name>
      <address>
        <city>Homburg</city>
        <zip>66421</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vinzenz-Hospital Köln</name>
      <address>
        <city>Köln</city>
        <zip>50733</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magyar Honvédség Honvédkorház</name>
      <address>
        <city>Budapest</city>
        <zip>1134</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Ospedale Niguarda Cà Granda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jantung Negara - National Heart Institute</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>50400</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstad Hospital Rotterdam</name>
      <address>
        <city>Rotterdam</city>
        <zip>3079 DZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario da Coruña</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Son Espases</name>
      <address>
        <city>Palma de Mallorca</city>
        <zip>07210</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago de Compostela</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE3 9QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </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>
  </location>
  <location>
    <facility>
      <name>Central Manchester University Hospitals NHS - Manchester Royal Infirmary</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The James Cook University Hospital - South Tees Hospitals NHS</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Canada</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Korea, Republic of</country>
    <country>Malaysia</country>
    <country>Netherlands</country>
    <country>Slovakia</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</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/NCT03232944
org study id: MPP PAS
nct id: NCT03232944
lead sponsor: 
is fda regulated drug: No
The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to
      improve CRT response in the non-responder patient population when used in "real-world"
      clinical practice, following commercial release. This evaluation is based on the Clinical
      Composite Score which summarizes the proportions and frequencies of CRT non-responder
      patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients
      will be followed for the duration of the PAS. This study is required by FDA as a condition of
      approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).
Medtronic market-released cardiac resynchronization therapy (CRT) Quadripolar (Quad) systems
      approved for commercial release with the Multiple Point Pacing (MPP) feature were eligible to
      contribute to the Post-Approval Study (PAS) objectives. Products with MPP capabilities
      receiving appropriate license or regulatory approval during the conduct of the PAS were
      included and contributed to the PAS objectives upon commercial release. CRT is an established
      pacing therapy for patients with heart failure (HF). CRT provides atrial- synchronized
      biventricular (BiV) pacing using standard pacing technology combined with a special third
      lead that is implanted via the coronary sinus and positioned in a cardiac vein to sense
      and/or pace the left ventricle (LV). Following a sensed atrial contraction or atrial paced
      event, both ventricles are stimulated to synchronize their contraction. The MPP feature is
      designed to allow a second LV pace to occur in LV Only or BiV pace configurations. In the LV
      Only pace configuration, the LV paces occur simultaneously or sequentially (LV- LV), as
      applicable by product. When Bi-V pacing is enabled, the RV pace can be delivered either
      before or after the LV paces, with the order determined by the programmed Ventricular Pacing
      Configuration.

      The MPP PAS was a global, prospective, observational multi-center study. Patients implanted
      with an eligible CRT Quad system were enrolled and followed in the Product Surveillance
      Registry per the expected standard of care practices of their care provider.
observational model: Cohort
time perspective: Prospective
measure: MPP therapy responder
time frame: Up to 3 years
description: To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT and had MPP programmed "on".
measure: HF hospitalization and/or mortality
time frame: Up to 3 years
description: Summarize incidence of HF hospitalization and/or mortality probability after MPP enabled
arm group label: CRT non-responders with MPP enabled
description: Patients enrolled and implanted with a CRT Quad system, who are identified as CRT non-responder, for which MPP is enabled.
intervention type: Device
intervention name: Cardiac Resynchronization Therapy - MPP
description: The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.
arm group label: CRT non-responders with MPP enabled
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
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country: Belgium
country: Canada
country: France
country: Germany
country: Hungary
country: Italy
country: Korea, Republic of
country: Malaysia
country: Netherlands
country: Slovakia
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Heart Failure