<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/NCT02227121</url>
  </required_header>
  <id_info>
    <org_study_id>ASD Study</org_study_id>
    <nct_id>NCT02227121</nct_id>
  </id_info>
  <brief_title>Acute Defibrillation Study</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic Cardiac Rhythm and Heart Failure</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic Cardiac Rhythm and Heart Failure</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study is designed to characterize defibrillation efficacy in humans for the&#xD;
      potential development of a new extravascular implantable cardioverter defibrillator (ICD)&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study recruited male and female subjects that met all of the inclusion criteria and none&#xD;
      of the exclusion criteria. All subjects were scheduled to undergo surgical procedures&#xD;
      outlined in the inclusion criteria. These surgical procedures were chosen as the patient&#xD;
      population for this study because these procedures require similar personnel and may require&#xD;
      access to similar or the same spaces as the ASD procedure.&#xD;
&#xD;
      The entire ASD study research system was removed prior to proceeding with the subject's&#xD;
      planned surgery per standard medical practice, which then proceeded according to the standard&#xD;
      of care.&#xD;
&#xD;
      Subjects were followed through their routine post-surgery follow-up visit.&#xD;
&#xD;
      At the time of completing the follow-up visit, the subjects' participation was complete and&#xD;
      the subjects exited the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sufficient enrollments under current protocol for further development &amp; studies&#xD;
  </why_stopped>
  <start_date>February 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Defibrillation Outcome</measure>
    <time_frame>Day of procedure</time_frame>
    <description>Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Ventricular Arrhythmias</condition>
  <arm_group>
    <arm_group_label>VT/VF induction and defibrillation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Defibrillation following induction of VT/VF</intervention_name>
    <description>Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.</description>
    <arm_group_label>VT/VF induction and defibrillation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be undergoing surgical procedure for approved indications for&#xD;
&#xD;
          -  cardiothoracic surgery where a midline sternotomy is planned, or&#xD;
&#xD;
          -  implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or&#xD;
&#xD;
          -  VT ablation procedure, or&#xD;
&#xD;
          -  VT inducibility testing during Electrophysiology (EP) study&#xD;
&#xD;
          -  Subject must be willing to provide Informed Consent&#xD;
&#xD;
          -  Subject must be ≥ 18 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is considered to be at high risk for infection&#xD;
&#xD;
          -  Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%&#xD;
&#xD;
          -  Subject at high risk of stroke&#xD;
&#xD;
          -  Subject with an implanted active cardiac or non-cardiac device during study procedure&#xD;
             (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)&#xD;
&#xD;
          -  Subject is pacemaker dependent&#xD;
&#xD;
          -  Subject had previous pericarditis or prior sternotomy&#xD;
&#xD;
          -  Subject has hiatus hernia or moderate or worse pectus excavatum&#xD;
&#xD;
          -  Subject has hypertrophic cardiomyopathy&#xD;
&#xD;
          -  Subject has severe aortic stenosis&#xD;
&#xD;
          -  Subject has severe proximal three vessel coronary disease (over 70% in each vessel)&#xD;
&#xD;
          -  Subject has &gt;50% left main stem (LMS) disease&#xD;
&#xD;
          -  Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode&#xD;
&#xD;
          -  Subject is enrolled in a concurrent study that may confound the results of this study,&#xD;
             without documented pre-approval from a Medtronic study manager&#xD;
&#xD;
          -  Subject has medical conditions that would limit study participation&#xD;
&#xD;
          -  Subject is pregnant&#xD;
&#xD;
          -  Subject meets exclusion criteria required by local law (e.g. age, breast feeding,&#xD;
             etc.)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krakowski Szpital Specjalistyczny im. Jana Pawla II</name>
      <address>
        <city>Krakow</city>
        <zip>31-202</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Heart and Chest Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>King's College Hospital</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <results_first_submitted>December 20, 2016</results_first_submitted>
  <results_first_submitted_qc>December 20, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2017</results_first_posted>
  <last_update_submitted>December 20, 2016</last_update_submitted>
  <last_update_submitted_qc>December 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2017</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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Enrolled Subjects</title>
          <description>All subjects consented for the study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Enrolled Subjects</title>
          <description>All subjects consented for the study.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
          </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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" lower_limit="54" upper_limit="70.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <title>Hong Kong</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>United Kingdom</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Poland</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Netherlands</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Indication for Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Cardiac Surgery: Coronary Artery Bypass Graft</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardiac Surgery: Valve Replacement</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Cardiac Surgery: Valve Repair</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Surgery Related to ICD (transvenous)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Surgery Related to S-ICD (subcutaneous ICD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Aortic Aneurysm</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Defibrillation Outcome</title>
        <description>Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.</description>
        <time_frame>Day of procedure</time_frame>
        <population>Only subjects with ventricular fibrillation successfully induced were eligible for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>VF Induction and Defibrillation</title>
            <description>Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.&#xD;
Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator.</description>
          </group>
        </group_list>
        <measure>
          <title>Defibrillation Outcome</title>
          <description>Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.</description>
          <population>Only subjects with ventricular fibrillation successfully induced were eligible for analysis</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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>VF Successfully Terminated with 35J shock</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>VF Not Successfully Terminated with 35J shock</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Null Hypothesis: Percentage of Subjects with Successful VF Termination ≤ 65% Alternative Hypothesis: Percentage of Subjects with Successful VF Termination &gt; 65%</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Percentage</param_type>
            <param_value>92.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>70.3</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline Assessment to routine Post-surgery follow-up visit.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Enrolled Subjects</title>
          <description>All subjects consented into the study</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Non-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="5" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Post-traumatic headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </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>Generally, contracts allow investigators to publish study results per the protocol and publication plan. Investigators and Participating Institutions will provide any publication of Study Data generated by PI and/or Participating Institution to Medtronic for review prior to submission to determine if confidential information (&quot;CI&quot;) is included and to check for technical correctness. Medtronic may not censor/interfere with the publication beyond the extent necessary to protect CI.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Griet Wouters</name_or_title>
      <organization>Medtronic Cardiac Rhythm and Heart Failure</organization>
      <phone>800-328-2518</phone>
      <email>MedtronicCRMtrials@medtronic.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/NCT02227121
org study id: ASD Study
nct id: NCT02227121
lead sponsor: 
has dmc: No
The proposed study is designed to characterize defibrillation efficacy in humans for the
      potential development of a new extravascular implantable cardioverter defibrillator (ICD)
      system.
The study recruited male and female subjects that met all of the inclusion criteria and none
      of the exclusion criteria. All subjects were scheduled to undergo surgical procedures
      outlined in the inclusion criteria. These surgical procedures were chosen as the patient
      population for this study because these procedures require similar personnel and may require
      access to similar or the same spaces as the ASD procedure.

      The entire ASD study research system was removed prior to proceeding with the subject's
      planned surgery per standard medical practice, which then proceeded according to the standard
      of care.

      Subjects were followed through their routine post-surgery follow-up visit.

      At the time of completing the follow-up visit, the subjects' participation was complete and
      the subjects exited the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Defibrillation Outcome
time frame: Day of procedure
description: Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.
arm group label: VT/VF induction and defibrillation
arm group type: Experimental
description: Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.
intervention type: Device
intervention name: Defibrillation following induction of VT/VF
description: Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.
arm group label: VT/VF induction and defibrillation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hong Kong
country: Netherlands
country: Poland
country: United Kingdom
responsible party type: Sponsor
mesh term: Arrhythmias, Cardiac
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 