<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/NCT03031847</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17010015</org_study_id>
    <nct_id>NCT03031847</nct_id>
  </id_info>
  <brief_title>Cardiac Resynchronization in the Elderly</brief_title>
  <official_title>Cardiac Resynchronization in the Elderly: Piloting Pacemaker vs. Defibrillator Therapy (Randomized Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samir Saba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at&#xD;
      the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State&#xD;
      University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P&#xD;
      versus CRT-D and followed until study end. Rates of patient screening, enrollment,&#xD;
      randomization, and retention as well as cost of care will be examined. The results of this&#xD;
      pilot study will inform the design of a large pivotal non-inferiority trial and will be&#xD;
      necessary for its success. Patients who refuse participation in the randomized pilot trial&#xD;
      will be asked to enroll in a prospective observational cohort. Characteristics of patients&#xD;
      who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their&#xD;
      device decision will be measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to pilot test a randomized, controlled, non-inferiority trial&#xD;
      comparing the survival and quality of life (QOL) of older patients receiving cardiac&#xD;
      resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This&#xD;
      pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the&#xD;
      hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State&#xD;
      University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P&#xD;
      versus CRT-D and followed until study end. Rates of patient screening, enrollment,&#xD;
      randomization, and retention as well as cost of care will be examined. The results of this&#xD;
      pilot study will inform the design of a large pivotal non-inferiority trial and will be&#xD;
      necessary for its success. Patients who refuse participation in the randomized pilot trial&#xD;
      will be enrolled and followed as part of a prospective observational cohort. Characteristics&#xD;
      of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction&#xD;
      with their device decision will be measured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">August 18, 2021</completion_date>
  <primary_completion_date type="Actual">August 18, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment</measure>
    <time_frame>At 1 year after start of the study</time_frame>
    <description>Rates of enrollment of participants in this randomized trial</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>QOL</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL2</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>Rates of retention of participants in this randomized trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Care Cost</measure>
    <time_frame>At 6 months after enrollment</time_frame>
    <description>Cost of health care between CRT-P and CRT-D recipients.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Randomized- Pacemaker (CRT-P)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cardiac resynchronization therapy Pacemaker</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Randomized- Defibrillator (CRT-D)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cardiac resynchronization therapy Defibrillator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational- Pacemaker (CRT-P)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Observational- Defibrillator (CRT-D)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization Therapy Pacemaker</intervention_name>
    <description>Patients randomized to the pacemaker arm will receive a CRT-P device.</description>
    <arm_group_label>Observational- Pacemaker (CRT-P)</arm_group_label>
    <arm_group_label>Randomized- Pacemaker (CRT-P)</arm_group_label>
    <other_name>CRT-P</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac Resynchronization Therapy Defibrillator</intervention_name>
    <description>Patients randomized to the defibrillator arm will receive a CRT-D device.</description>
    <arm_group_label>Observational- Defibrillator (CRT-D)</arm_group_label>
    <arm_group_label>Randomized- Defibrillator (CRT-D)</arm_group_label>
    <other_name>CRT-D</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;/= 75 years&#xD;
&#xD;
          2. Left Ventricular Ejection Fraction (LVEF) ≤ 35% by cardiac imaging including&#xD;
             echocardiogram, nuclear imaging, cardiac catheterization, or cardiac magnetic&#xD;
             resonance imaging&#xD;
&#xD;
          3. QRS width &gt;120 ms on surface electrocardiogram&#xD;
&#xD;
          4. New York Heart Association class II, III, or ambulatory IV for Heart Failure (HF)&#xD;
&#xD;
          5. Patient undergoing de novo CRT device implantation of CRT-D device change-out for&#xD;
             battery depletion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient within 40 days of acute myocardial infarction&#xD;
&#xD;
          2. Patient within 3 months of cardiac revascularization (percutaneous coronary&#xD;
             intervention or bypass surgery)&#xD;
&#xD;
          3. Patient with prior history of cardiac arrest or documented sustained ventricular&#xD;
             arrhythmia&#xD;
&#xD;
          4. Patient with expected longevity &lt; 1 year&#xD;
&#xD;
          5. Patient not on optimal medical therapy for HF management including when tolerated&#xD;
             β-blockers, angiotensin converting enzyme inhibitors or angiotensin receptor blockers&#xD;
&#xD;
          6. Patient not planning to have his/her follow-up at participating institution&#xD;
&#xD;
          7. Patient unable or unwilling to sign a written informed consent&#xD;
&#xD;
          8. Patient's with dementia that are unable to consent for themselves&#xD;
&#xD;
          9. Participating in any other clinical trials (observational/registries allowed)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Saba, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Health System</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hamot</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Research Foundation of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Pinnacle</name>
      <address>
        <city>Wormleysburg</city>
        <state>Pennsylvania</state>
        <zip>17043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <results_first_submitted>July 19, 2022</results_first_submitted>
  <results_first_submitted_qc>July 27, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 23, 2022</results_first_posted>
  <last_update_submitted>July 27, 2022</last_update_submitted>
  <last_update_submitted_qc>July 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Samir Saba</investigator_full_name>
    <investigator_title>Associate Professor &lt;Me; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology;</investigator_title>
  </responsible_party>
  <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>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/47/NCT03031847/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Randomized- Pacemaker (CRT-P)</title>
          <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
        </group>
        <group group_id="P2">
          <title>Randomized- Defibrillator (CRT-D)</title>
          <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
        </group>
        <group group_id="P3">
          <title>Observational- Pacemaker (CRT-P)</title>
          <description>Patients in observational arm that chose CRT-P device</description>
        </group>
        <group group_id="P4">
          <title>Observational- Defibrillator (CRT-D)</title>
          <description>Patients in observational arm that chose CRT-D device</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="18"/>
                <participants group_id="P4" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="14"/>
                <participants group_id="P4" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Randomized- Pacemaker (CRT-P)</title>
          <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
        </group>
        <group group_id="B2">
          <title>Randomized- Defibrillator (CRT-D)</title>
          <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
        </group>
        <group group_id="B3">
          <title>Observational- Pacemaker (CRT-P)</title>
          <description>Patients in observational arm that chose CRT-P device</description>
        </group>
        <group group_id="B4">
          <title>Observational- Defibrillator (CRT-D)</title>
          <description>Patients in observational arm that chose CRT-D device</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="42"/>
            <count group_id="B5" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80.7" spread="4.3"/>
                    <measurement group_id="B2" value="81.4" spread="4.9"/>
                    <measurement group_id="B3" value="84.7" spread="4.6"/>
                    <measurement group_id="B4" value="80.6" spread="4.0"/>
                    <measurement group_id="B5" value="81.5" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="34"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="38"/>
                    <measurement group_id="B5" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="18"/>
                    <measurement group_id="B4" value="42"/>
                    <measurement group_id="B5" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Enrollment</title>
        <description>Rates of enrollment of participants in this randomized trial</description>
        <time_frame>At 1 year after start of the study</time_frame>
        <population>Participants Enrolled</population>
        <group_list>
          <group group_id="O1">
            <title>Randomized- Pacemaker (CRT-P)</title>
            <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
          </group>
          <group group_id="O2">
            <title>Randomized- Defibrillator (CRT-D)</title>
            <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
          </group>
          <group group_id="O3">
            <title>Observational- Pacemaker (CRT-P)</title>
            <description>Patients in observational arm that chose CRT-P device</description>
          </group>
          <group group_id="O4">
            <title>Observational- Defibrillator (CRT-D)</title>
            <description>Patients in observational arm that chose CRT-D device</description>
          </group>
        </group_list>
        <measure>
          <title>Enrollment</title>
          <description>Rates of enrollment of participants in this randomized trial</description>
          <population>Participants Enrolled</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>QOL</title>
        <description>Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <population>Only participants with complete 6-month data for QoL assessments were reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Randomized- Pacemaker (CRT-P)</title>
            <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
          </group>
          <group group_id="O2">
            <title>Randomized- Defibrillator (CRT-D)</title>
            <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
          </group>
          <group group_id="O3">
            <title>Observational- Pacemaker (CRT-P)</title>
            <description>Patients in observational arm that chose CRT-P device</description>
          </group>
          <group group_id="O4">
            <title>Observational- Defibrillator (CRT-D)</title>
            <description>Patients in observational arm that chose CRT-D device</description>
          </group>
        </group_list>
        <measure>
          <title>QOL</title>
          <description>Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.</description>
          <population>Only participants with complete 6-month data for QoL assessments were reported.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall QOL: MLWHF Questionnaire</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.5" spread="30.3"/>
                    <measurement group_id="O2" value="16.1" spread="19.6"/>
                    <measurement group_id="O3" value="18.4" spread="9.6"/>
                    <measurement group_id="O4" value="37.8" spread="24.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical QOL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" spread="13.8"/>
                    <measurement group_id="O2" value="8.2" spread="9.4"/>
                    <measurement group_id="O3" value="10.7" spread="7.7"/>
                    <measurement group_id="O4" value="18.9" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional QOL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" spread="7.9"/>
                    <measurement group_id="O2" value="3.5" spread="5.4"/>
                    <measurement group_id="O3" value="2.9" spread="2.8"/>
                    <measurement group_id="O4" value="7.5" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>QOL2</title>
        <description>QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <population>Only participants with complete 6-month data for QoL assessments were reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Randomized- Pacemaker (CRT-P)</title>
            <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
          </group>
          <group group_id="O2">
            <title>Randomized- Defibrillator (CRT-D)</title>
            <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
          </group>
          <group group_id="O3">
            <title>Observational- Pacemaker (CRT-P)</title>
            <description>Patients in observational arm that chose CRT-P device</description>
          </group>
          <group group_id="O4">
            <title>Observational- Defibrillator (CRT-D)</title>
            <description>Patients in observational arm that chose CRT-D device</description>
          </group>
        </group_list>
        <measure>
          <title>QOL2</title>
          <description>QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.</description>
          <population>Only participants with complete 6-month data for QoL assessments were reported.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="12"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rand-36: PCS-T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.4" spread="14.5"/>
                    <measurement group_id="O2" value="45.0" spread="12.4"/>
                    <measurement group_id="O3" value="37.7" spread="10.5"/>
                    <measurement group_id="O4" value="35.0" spread="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rand-36: MCS-T</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0" spread="13.4"/>
                    <measurement group_id="O2" value="51.4" spread="10.4"/>
                    <measurement group_id="O3" value="51.6" spread="10.4"/>
                    <measurement group_id="O4" value="47.7" spread="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Retention</title>
        <description>Rates of retention of participants in this randomized trial</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Randomized- Pacemaker (CRT-P)</title>
            <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
          </group>
          <group group_id="O2">
            <title>Randomized- Defibrillator (CRT-D)</title>
            <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
          </group>
          <group group_id="O3">
            <title>Observational- Pacemaker (CRT-P)</title>
            <description>Patients in observational arm that chose CRT-P device</description>
          </group>
          <group group_id="O4">
            <title>Observational- Defibrillator (CRT-D)</title>
            <description>Patients in observational arm that chose CRT-D device</description>
          </group>
        </group_list>
        <measure>
          <title>Retention</title>
          <description>Rates of retention of participants in this randomized trial</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="20"/>
                <count group_id="O3" value="18"/>
                <count group_id="O4" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Care Cost</title>
        <description>Cost of health care between CRT-P and CRT-D recipients.</description>
        <time_frame>At 6 months after enrollment</time_frame>
        <population>Data was not collected</population>
        <group_list>
          <group group_id="O1">
            <title>Randomized- Pacemaker (CRT-P)</title>
            <description>Patients assigned to the pacemaker arm will receive CRT-P device</description>
          </group>
          <group group_id="O2">
            <title>Randomized- Defibrillator (CRT-D)</title>
            <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
          </group>
          <group group_id="O3">
            <title>Observational- Pacemaker (CRT-P)</title>
            <description>Patients in observational arm that chose CRT-P device</description>
          </group>
          <group group_id="O4">
            <title>Observational- Defibrillator (CRT-D)</title>
            <description>Patients in observational arm that chose CRT-D device</description>
          </group>
        </group_list>
        <measure>
          <title>Health Care Cost</title>
          <description>Cost of health care between CRT-P and CRT-D recipients.</description>
          <population>Data was not collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 24 months.</time_frame>
      <desc>Adverse events were collected and classified as serious or not serious, cardiac or not cardiac. Cardiac events were further differentiated by arrhythmic or non-arrhythmic. Adverse events were not classified by specific organ system.</desc>
      <group_list>
        <group group_id="E1">
          <title>Randomized- Pacemaker (CRT-P)</title>
          <description>Patients assigned to the pacemaker arm will receive CRT-P device.</description>
        </group>
        <group group_id="E2">
          <title>Randomized- Defibrillator (CRT-D)</title>
          <description>Patients assigned to the defibrillator arm will receive CRT-D device</description>
        </group>
        <group group_id="E3">
          <title>Observational- Pacemaker (CRT-P)</title>
          <description>Patients in observational arm that chose CRT-P device</description>
        </group>
        <group group_id="E4">
          <title>Observational- Defibrillator (CRT-D)</title>
          <description>Patients in observational arm that chose CRT-D device</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="17" subjects_at_risk="42"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="14" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Cardiac</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Cardiac</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Eric Pasquantonio</name_or_title>
      <organization>UPMC Presbyterian Hospital</organization>
      <phone>4126478210</phone>
      <email>pasquantonioej@upmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03031847
org study id: PRO17010015
nct id: NCT03031847
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at
      the hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State
      University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P
      versus CRT-D and followed until study end. Rates of patient screening, enrollment,
      randomization, and retention as well as cost of care will be examined. The results of this
      pilot study will inform the design of a large pivotal non-inferiority trial and will be
      necessary for its success. Patients who refuse participation in the randomized pilot trial
      will be asked to enroll in a prospective observational cohort. Characteristics of patients
      who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction with their
      device decision will be measured.
The goal of this study is to pilot test a randomized, controlled, non-inferiority trial
      comparing the survival and quality of life (QOL) of older patients receiving cardiac
      resynchronization therapy (CRT) pacemaker (CRT-P) versus defibrillator (CRT-D) therapy. This
      pilot will enroll 50 HF patients (age ≥ 75 years) undergoing CRT device implantation at the
      hospitals of the University of Pittsburgh Medical Center, Duke University, Ohio State
      University, and the VA Pittsburgh Healthcare System. Patients will be randomized to CRT-P
      versus CRT-D and followed until study end. Rates of patient screening, enrollment,
      randomization, and retention as well as cost of care will be examined. The results of this
      pilot study will inform the design of a large pivotal non-inferiority trial and will be
      necessary for its success. Patients who refuse participation in the randomized pilot trial
      will be enrolled and followed as part of a prospective observational cohort. Characteristics
      of patients who choose CRT-P vs. CRT-D will be compared and patients' level of satisfaction
      with their device decision will be measured.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, open-label, controlled trial of CRT-P vs. CRT-D in HF patients (age ≥ 75 years)
primary purpose: Treatment
masking: None (Open Label)
measure: Enrollment
time frame: At 1 year after start of the study
description: Rates of enrollment of participants in this randomized trial
measure: QOL
time frame: At 6 months after enrollment
description: Quality of life of CRT-P versus CRT-D recipients using Minnesota Living with Heart Failure Questionnaires. The Minnesota Living with Heart Failure scale ranges from 0 to 105, in which a lower score indicates a better outcome. The Minnesota Living with Heart Failure Physical subscale ranges from 0 to 40 and the Minnesota Living with Heart Failure Mental subscale ranges from 0 to 25. Lower scores on the subscales indicate a better outcome.
measure: QOL2
time frame: At 6 months after enrollment
description: QOL of CRT-P versus CRT-D recipients using RAND-36. The RAND-36 is a normalized scale with a range of 0 to 100, in which a higher score is indicative of a better outcome. PCS-T and MCS-T are the two summary components of the RAND-36. The subscales PCS-T and MCS-T are both normalized with a range of 0 to 100. Higher scores on the subscales indicate a better outcome.
measure: Retention
time frame: At 6 months after enrollment
description: Rates of retention of participants in this randomized trial
measure: Health Care Cost
time frame: At 6 months after enrollment
description: Cost of health care between CRT-P and CRT-D recipients.
arm group label: Randomized- Pacemaker (CRT-P)
arm group type: Other
description: Cardiac resynchronization therapy Pacemaker
arm group label: Randomized- Defibrillator (CRT-D)
arm group type: Other
description: Cardiac resynchronization therapy Defibrillator
arm group label: Observational- Pacemaker (CRT-P)
arm group type: Other
description: Cardiac resynchronization therapy Pacemaker (CRT-P): Patients in this arm declined randomization in the trial and elected to participate in the observational registry
arm group label: Observational- Defibrillator (CRT-D)
arm group type: Other
description: Cardiac resynchronization therapy Defibrillator (CRT-D): Patients in this arm declined randomization in the trial and elected to participate in the observational registry
intervention type: Device
intervention name: Cardiac Resynchronization Therapy Pacemaker
description: Patients randomized to the pacemaker arm will receive a CRT-P device.
arm group label: Observational- Pacemaker (CRT-P)
arm group label: Randomized- Pacemaker (CRT-P)
other name: CRT-P
intervention type: Device
intervention name: Cardiac Resynchronization Therapy Defibrillator
description: Patients randomized to the defibrillator arm will receive a CRT-D device.
arm group label: Observational- Defibrillator (CRT-D)
arm group label: Randomized- Defibrillator (CRT-D)
other name: CRT-D
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Samir Saba, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Samir Saba
investigator title: Associate Professor <Me; Associate Chief of Cardiology; Director of Cardiovascular Electrophysiology;
mesh term: Heart Failure
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 