<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/NCT03035227</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00003861</org_study_id>
    <nct_id>NCT03035227</nct_id>
  </id_info>
  <brief_title>Catheter Ablation of Arrhythmias to Improve CRT Response</brief_title>
  <acronym>ABLATE-CRT</acronym>
  <official_title>Catheter Ablation of Arrhythmias to Improve CRT Response</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kansas City Heart Rhythm Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Kansas City Heart Rhythm Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test if catheter ablation is better than medication therapy&#xD;
      at treating arrhythmias originating from the upper and/or lower chambers of the heart in&#xD;
      order to allow the heart to beat properly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Investigator left Institution.&#xD;
  </why_stopped>
  <start_date type="Actual">January 23, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Ejection Fraction (EF)</measure>
    <time_frame>90 Days</time_frame>
    <description>Change in Ejection Fraction (EF)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bi-ventricular Pacing Improvement</measure>
    <time_frame>90 Days</time_frame>
    <description>data not analyzed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular Mortality</measure>
    <time_frame>365Days</time_frame>
    <description>data not analyzed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>365 Days</time_frame>
    <description>data was not analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admissions for Heart Failure Exacerbation</measure>
    <time_frame>365 Days</time_frame>
    <description>data not analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New York Heart Association (NYHA) Class Change</measure>
    <time_frame>30 Days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minute Walk Test</measure>
    <time_frame>30 Days</time_frame>
    <description>data not analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life - SF-36</measure>
    <time_frame>30 Days</time_frame>
    <description>data not analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)</measure>
    <time_frame>30 Days</time_frame>
    <description>data not analyzed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Arrhythmia, Cardiac</condition>
  <arm_group>
    <arm_group_label>Catheter Ablation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Catheter ablation procedure of atrial and/or ventricular arrhythmias.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Medical management using antiarrhythmic drugs per standard of care of treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Catheter Ablation</intervention_name>
    <description>Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.</description>
    <arm_group_label>Catheter Ablation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anti-Arrhythmics</intervention_name>
    <description>Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.</description>
    <arm_group_label>Medical Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Heart failure patients with CRT-D or CRT-P greater than 3 months&#xD;
&#xD;
          -  Bi-ventricular pacing less than 94% of the time&#xD;
&#xD;
          -  3 months after CRT-D or CRT-P implantation an EF improvement less than 5%&#xD;
&#xD;
          -  Presence of one of the following arrhythmias and eligible for catheter ablation:&#xD;
&#xD;
          -  Atrial fibrillation&#xD;
&#xD;
          -  Atrial flutter&#xD;
&#xD;
          -  Supraventricular tachycardia&#xD;
&#xD;
          -  Premature ventricular contraction burden greater than 30% in a 24-hour period&#xD;
&#xD;
          -  Ventricular tachycardia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Estimated survival less than one year&#xD;
&#xD;
          -  Patient unable to make scheduled follow up visits at treating center&#xD;
&#xD;
          -  Participating in another investigational study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dhanunjaya Lakkireddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kansas City Heart Rhythm Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>April 16, 2020</results_first_submitted>
  <results_first_submitted_qc>August 17, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 10, 2022</results_first_posted>
  <last_update_submitted>August 17, 2022</last_update_submitted>
  <last_update_submitted_qc>August 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</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>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Arrhythmia Agents</mesh_term>
  </intervention_browse>
  <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>March 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03035227/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Medical Therapy</title>
          <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
        </group>
        <group group_id="P2">
          <title>Ablation Arm</title>
          <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0">study stopped due to PI leaving institution</participants>
                <participants group_id="P2" count="0">study stopped due to PI leaving institution</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>study stopped due to PI leaving institut</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>data not collected to be analyzed</population>
      <group_list>
        <group group_id="B1">
          <title>Catheter Ablation</title>
          <description>Catheter ablation procedure of atrial and/or ventricular arrhythmias.&#xD;
Catheter Ablation: Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.</description>
        </group>
        <group group_id="B2">
          <title>Medical Therapy</title>
          <description>Medical management using antiarrhythmic drugs per standard of care of treating physician.&#xD;
Anti-Arrhythmics: Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.</description>
        </group>
        <group group_id="B3">
          <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="0"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="0"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                </category>
                <category>
                  <title>Male</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                </category>
                <category>
                  <title>Asian</title>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                </category>
                <category>
                  <title>Black or African American</title>
                </category>
                <category>
                  <title>White</title>
                </category>
                <category>
                  <title>More than one race</title>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <class_list>
            <class>
              <title>United States</title>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Ejection Fraction (EF)</title>
        <description>Change in Ejection Fraction (EF)</description>
        <time_frame>90 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Ejection Fraction (EF)</title>
          <description>Change in Ejection Fraction (EF)</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Bi-ventricular Pacing Improvement</title>
        <description>data not analyzed</description>
        <time_frame>90 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>Bi-ventricular Pacing Improvement</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Cardiovascular Mortality</title>
        <description>data not analyzed</description>
        <time_frame>365Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiovascular Mortality</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Mortality</title>
        <description>data was not analyzed</description>
        <time_frame>365 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>data was not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Admissions for Heart Failure Exacerbation</title>
        <description>data not analyzed</description>
        <time_frame>365 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Admissions for Heart Failure Exacerbation</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>New York Heart Association (NYHA) Class Change</title>
        <time_frame>30 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>New York Heart Association (NYHA) Class Change</title>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in 6 Minute Walk Test</title>
        <description>data not analyzed</description>
        <time_frame>30 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
          <group group_id="O2">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in 6 Minute Walk Test</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life - SF-36</title>
        <description>data not analyzed</description>
        <time_frame>30 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
          <group group_id="O2">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life - SF-36</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
        <description>data not analyzed</description>
        <time_frame>30 Days</time_frame>
        <population>data not analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Ablation Arm</title>
            <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
          </group>
          <group group_id="O2">
            <title>Medical Therapy</title>
            <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)</title>
          <description>data not analyzed</description>
          <population>data not analyzed</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were not monitored/assessed.</time_frame>
      <desc>Adverse Events were not monitored/assessed. No data collected - enrolled two patients and that is all. Study was cancelled.</desc>
      <group_list>
        <group group_id="E1">
          <title>Medical Therapy</title>
          <description>The medical treatment arm consist of the use of antiarrhythmic drugs that are deemed to be appropriate for the given arrhythmia by the treating physician.</description>
        </group>
        <group group_id="E2">
          <title>Ablation Arm</title>
          <description>Patients enrolled into the ablation arm will under go catheter ablation of atrial or ventricular arrhythmia within 3 months of signing the informed consent form.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>Dr. Dhanunjaya Lakkireddy</name_or_title>
      <organization>Kansas City Heart Rhythm Institute</organization>
      <phone>913-449-1297</phone>
      <email>dhanunjaya.lakkireddy@hcahealthcare.com</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/NCT03035227
org study id: STUDY00003861
nct id: NCT03035227
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to test if catheter ablation is better than medication therapy
      at treating arrhythmias originating from the upper and/or lower chambers of the heart in
      order to allow the heart to beat properly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in Ejection Fraction (EF)
time frame: 90 Days
description: Change in Ejection Fraction (EF)
measure: Bi-ventricular Pacing Improvement
time frame: 90 Days
description: data not analyzed
measure: Cardiovascular Mortality
time frame: 365Days
description: data not analyzed
measure: All-cause Mortality
time frame: 365 Days
description: data was not analyzed
measure: Hospital Admissions for Heart Failure Exacerbation
time frame: 365 Days
description: data not analyzed
measure: New York Heart Association (NYHA) Class Change
time frame: 30 Days
measure: Change in 6 Minute Walk Test
time frame: 30 Days
description: data not analyzed
measure: Change in Quality of Life - SF-36
time frame: 30 Days
description: data not analyzed
measure: Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 30 Days
description: data not analyzed
arm group label: Catheter Ablation
arm group type: Active Comparator
description: Catheter ablation procedure of atrial and/or ventricular arrhythmias.
arm group label: Medical Therapy
arm group type: Active Comparator
description: Medical management using antiarrhythmic drugs per standard of care of treating physician.
intervention type: Procedure
intervention name: Catheter Ablation
description: Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.
arm group label: Catheter Ablation
intervention type: Drug
intervention name: Anti-Arrhythmics
description: Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
arm group label: Medical Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Dhanunjaya Lakkireddy, MD
role: Principal Investigator
affiliation: Kansas City Heart Rhythm Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
mesh term: Anti-Arrhythmia Agents
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 