<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/NCT03001141</url>
  </required_header>
  <id_info>
    <org_study_id>U1111-1190-5280</org_study_id>
    <nct_id>NCT03001141</nct_id>
  </id_info>
  <brief_title>Study Protocol/ Registry of MultiPoint™ Pacing in Brazil</brief_title>
  <official_title>Study Protocol/ Registry of MultiPoint™ Pacing in Brazil</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, non-randomized registry/observational study. The study&#xD;
      will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac&#xD;
      Resynchronization Therapy (CRT) MP device implant from up to 10 centers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model&#xD;
      quadripolar device with MPP capability and who meets the inclusion criteria and none of the&#xD;
      exclusion criteria is eligible for enrollment in the study.&#xD;
&#xD;
      Patients will be followed for 12 months after implant. Data will be collected after device&#xD;
      implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and&#xD;
      during unscheduled visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Ethic Comitte (CONEP) determinated the prematurely terminated.&#xD;
  </why_stopped>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Actual">February 8, 2019</completion_date>
  <primary_completion_date type="Actual">April 18, 2018</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>12 Months</target_duration>
  <primary_outcome>
    <measure>Cardiac resynchronization therapy response rate measured by Clinical Composite Score</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life changes, measured by MLWHF questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life changes, measured by EQ-5D questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular ejection fraction</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in left ventricular end systolic volume</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Programming strategy used (vector and intervals), obtained from the Device Session records</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart failure hospitalization rate</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause mortality</measure>
    <time_frame>12 months</time_frame>
    <description>Evaluated on regular medical visits and registered in the CRF</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Heart Failure, Unspecified</condition>
  <arm_group>
    <arm_group_label>Single group - observational</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.</description>
    <arm_group_label>Single group - observational</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model&#xD;
        quadripolar device with MPP capability and who meets the inclusion criteria and none of the&#xD;
        exclusion criteria is eligible for enrollment in the study.&#xD;
&#xD;
        Patients will be followed for 12 months after implant. Data will be collected after device&#xD;
        implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and&#xD;
        during unscheduled visits.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient willing and able to sign Informed Consent Form&#xD;
&#xD;
          -  Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model&#xD;
             quadripolar device with MPP capability&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is likely to undergo a heart transplantation within 12 months&#xD;
&#xD;
          -  Is less than 18 years old&#xD;
&#xD;
          -  Is pregnant or is planning to get pregnant during the study&#xD;
&#xD;
          -  Is currently taking part in a Clinical Trial with an active treatment group&#xD;
&#xD;
          -  Life expectancy is under 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marco Aurelio Santos</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Devices</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinica Dom Rodrigo</name>
      <address>
        <city>João Pessoa</city>
        <state>PB</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01323-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Arritmias Cardíacas</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01323-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SEMAP</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>04.004-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MultiPoint Pacing</keyword>
  <keyword>Heart Failure</keyword>
  <keyword>Cardiac Resynchronization Therapy</keyword>
  <keyword>Quadripolar pacing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03001141
org study id: U1111-1190-5280
nct id: NCT03001141
lead sponsor: 
has dmc: No
This is a prospective, multicenter, non-randomized registry/observational study. The study
      will enroll up to 200 patients with successful St. Jude Medical (SJM) Cardiac
      Resynchronization Therapy (CRT) MP device implant from up to 10 centers.
Any patient receiving a market-approved SJM Quadra Assura MP (CRT-D) or newer model
      quadripolar device with MPP capability and who meets the inclusion criteria and none of the
      exclusion criteria is eligible for enrollment in the study.

      Patients will be followed for 12 months after implant. Data will be collected after device
      implant (up to 30 days after successful implant), at 3, 6 and 12 months post-implant and
      during unscheduled visits.
observational model: Cohort
time perspective: Prospective
measure: Cardiac resynchronization therapy response rate measured by Clinical Composite Score
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Quality of Life changes, measured by MLWHF questionnaire
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Quality of Life changes, measured by EQ-5D questionnaire
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Change in left ventricular ejection fraction
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Change in left ventricular end systolic volume
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Programming strategy used (vector and intervals), obtained from the Device Session records
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: Heart failure hospitalization rate
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
measure: All-cause mortality
time frame: 12 months
description: Evaluated on regular medical visits and registered in the CRF
arm group label: Single group - observational
intervention type: Other
intervention name: Observational
description: Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.
arm group label: Single group - observational
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marco Aurelio Santos
role: Study Director
affiliation: Abbott Medical Devices
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: Undecided