<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/NCT03242941</url>
  </required_header>
  <id_info>
    <org_study_id>AF Septal Pacing</org_study_id>
    <nct_id>NCT03242941</nct_id>
  </id_info>
  <brief_title>AF Septal Pacing (Clinical Investigation Plan)</brief_title>
  <official_title>AF Septal Pacing (Clinical Investigation Plan)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medtronic BRC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medtronic BRC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this non-randomized, non-controlled, acute, single-arm research study is to&#xD;
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on&#xD;
      the interatrial septum. The possibility to terminate atrial arrythmias will also be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The evidence of treating AF by pacing is limited, although these algorithms are of interest,&#xD;
      since they appear to be safe and usually add little additional cost.&#xD;
&#xD;
      Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal&#xD;
      pacing algorithm could suppress AF reentries in a more robust way than classical single site&#xD;
      rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed&#xD;
      in the interatrial septum has been previously demonstrated clinically. The septal pacing&#xD;
      concept has also been successfully tested in a computer model of AF and in a pig model .&#xD;
      Experimental studies are now needed to determine whether similar termination mechanisms and&#xD;
      efficacies can be observed in humans.&#xD;
&#xD;
      The purpose of this non-randomized, non-controlled, acute, single-arm research study is to&#xD;
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on&#xD;
      the interatrial septum&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">July 20, 2018</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>
    <intervention_model_description>Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Electrodes in a Stable Position</measure>
    <time_frame>30 minutes</time_frame>
    <description>To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be &lt; 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Localized Atrial Capture</measure>
    <time_frame>30 minutes</time_frame>
    <description>To assess Localized Atrial Capture the following endpoints will be considered:&#xD;
- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Termination of Atrial Tachyarrhythmia.</measure>
    <time_frame>30 minutes</time_frame>
    <description>Termination of atrial tachyarrhythmia.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Persistent and Paroxtmal AF Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary vein ablation</intervention_name>
    <description>After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.</description>
    <arm_group_label>Persistent and Paroxtmal AF Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient referred to the center to undergo ablation of the pulmonary vein using&#xD;
             radiofrequency (initial AF ablation, or redo procedure).&#xD;
&#xD;
          -  In case of paroxysmal AF the right atrium should be dilated as indicated by &gt; 29 ml&#xD;
             mm2 or the left atrium should be dilated as indicated by &gt; 34 ml mm2.&#xD;
&#xD;
          -  Patient is willing and able to cooperate with the study procedure.&#xD;
&#xD;
          -  Patient is willing to provide the Informed Consent for their participation in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years or over 80 years old.&#xD;
&#xD;
          -  Women who are currently pregnant or have a positive pregnancy test.&#xD;
&#xD;
          -  Patients with an implantable cardiac device.&#xD;
&#xD;
          -  Patients who already underwent an AF septal ablation procedure.&#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>Lucas V.A. Boersma</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Antonius Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gottsegen György Országos Kardiológiai Intézet</name>
      <address>
        <city>Budapest</city>
        <zip>1096</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht Universitair Medisch Centrum (MUMC)</name>
      <address>
        <city>Maastricht</city>
        <zip>6229 HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435 CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <results_first_submitted>February 22, 2019</results_first_submitted>
  <results_first_submitted_qc>February 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 20, 2019</results_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</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>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 22, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03242941/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03242941/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>If the pulmonary vein ablation succeeded and the subject was in sinus rhythm the study procedure started from the electrode testing. Alternatively, if the subject was still in AF, the electrode testing was performed after either the application of the dual stage pacing algorithm or the cardioversion, when the sinus rhythm was established.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Persisten and Paroxymal AF Patients</title>
          <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination.</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="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Paroxymal and Persistent AF Patients</title>
          <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="55" spread="13"/>
                  </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="2"/>
                  </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="0"/>
                  </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="14"/>
                  </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>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="182" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="92" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Electrodes in a Stable Position</title>
        <description>To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be &lt; 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.</description>
        <time_frame>30 minutes</time_frame>
        <population>The maximum number of electrode pairs used and potentially stable</population>
        <group_list>
          <group group_id="O1">
            <title>Paroxymal and Persistent AF Patients</title>
            <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Electrodes in a Stable Position</title>
          <description>To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be &lt; 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.</description>
          <population>The maximum number of electrode pairs used and potentially stable</population>
          <units>Electrode pairs</units>
          <param>Count of Units</param>
          <units_analyzed>Electrode pairs</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Electrode pairs</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Localized Atrial Capture</title>
        <description>To assess Localized Atrial Capture the following endpoints will be considered:&#xD;
- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions</description>
        <time_frame>30 minutes</time_frame>
        <population>Patient treated with the new pacing scheme algorithm</population>
        <group_list>
          <group group_id="O1">
            <title>Paroxymal or Persistent AF Patients</title>
            <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well</description>
          </group>
        </group_list>
        <measure>
          <title>Localized Atrial Capture</title>
          <description>To assess Localized Atrial Capture the following endpoints will be considered:&#xD;
- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions</description>
          <population>Patient treated with the new pacing scheme algorithm</population>
          <units>Episodes</units>
          <param>Count of Units</param>
          <units_analyzed>Episodes</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Episodes</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Termination of Atrial Tachyarrhythmia.</title>
        <description>Termination of atrial tachyarrhythmia.</description>
        <time_frame>30 minutes</time_frame>
        <population>Patients treated with the new dual stage pacing algorithm</population>
        <group_list>
          <group group_id="O1">
            <title>Paroxymal or Persistent AF Patients</title>
            <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well</description>
          </group>
        </group_list>
        <measure>
          <title>Termination of Atrial Tachyarrhythmia.</title>
          <description>Termination of atrial tachyarrhythmia.</description>
          <population>Patients treated with the new dual stage pacing algorithm</population>
          <units>AF termination occurrence</units>
          <param>Count of Units</param>
          <units_analyzed>AF termination occurrence</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>AF termination occurrence</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Since AF Septal Pacing is an acute study with no follow up and patient exit at the end of the procedure, only AE occurred during the procedure were recorded.</time_frame>
      <desc>Adverse Events were evaluated according to ISO 14155:2011</desc>
      <group_list>
        <group group_id="E1">
          <title>Paroxymal and Persistent AF Patients</title>
          <description>Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation.&#xD;
Pulmonary vein ablation: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters will be assessed as well as AF termination.</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="14"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <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="1" subjects_at_risk="14"/>
              </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="14"/>
              </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>Lilian Kornet</name_or_title>
      <organization>Medtronic</organization>
      <phone>+31433566710</phone>
      <email>lilian.kornet@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/NCT03242941
org study id: AF Septal Pacing
nct id: NCT03242941
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this non-randomized, non-controlled, acute, single-arm research study is to
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on
      the interatrial septum. The possibility to terminate atrial arrythmias will also be
      evaluated.
The evidence of treating AF by pacing is limited, although these algorithms are of interest,
      since they appear to be safe and usually add little additional cost.

      Using a computer model, a new dual-stage septal pacing has been developed.The proposed septal
      pacing algorithm could suppress AF reentries in a more robust way than classical single site
      rapid pacing. The feasibility of pacing both atria simultaneously from a single lead placed
      in the interatrial septum has been previously demonstrated clinically. The septal pacing
      concept has also been successfully tested in a computer model of AF and in a pig model .
      Experimental studies are now needed to determine whether similar termination mechanisms and
      efficacies can be observed in humans.

      The purpose of this non-randomized, non-controlled, acute, single-arm research study is to
      evaluate the feasibility to obtain a stable position of a ring of stimulation electrodes on
      the interatrial septum
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Approximately 15 subjects with AF indicated for ablation of the pulmonary vein will be enrolled in the study. Participants will attend the Baseline visit and the Procedure visit. The baseline visit can be on the same day as the ablation procedure. Since it is an acute study, no follow-up visit will occur. The research procedure will be performed during an already scheduled ablation procedure. Subjects will be enrolled over a period of approximately 18 months
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Electrodes in a Stable Position
time frame: 30 minutes
description: To assess Pacing Site Stability, the number of interatrial septal pacing electrodes which are successfully placed in a stable position, will be counted. A stable position in this study is defined as a location where the pacing threshold will be < 10 mA at a pacing pulse width of 1 msec. Stable pacing further requires that no ventricular capture will be induced during atrial stimulation at twice the atrial capture threshold.
measure: Localized Atrial Capture
time frame: 30 minutes
description: To assess Localized Atrial Capture the following endpoints will be considered:
- the number of AF episodes in which local capture is recorded during atrial septal stimulation in at least one of the electrode positions
measure: Termination of Atrial Tachyarrhythmia.
time frame: 30 minutes
description: Termination of atrial tachyarrhythmia.
arm group label: Persistent and Paroxtmal AF Patients
arm group type: Experimental
description: Patients with either paroxymal or persistent AF already referred to the center for Pulmonary Vein Ablation will be stimulated delivering a novel dual-stage pacing protocol to terminate atrial fibrillation usinf a ring of electrodes positioned on the septum.
intervention type: Procedure
intervention name: Pulmonary vein ablation
description: After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.
arm group label: Persistent and Paroxtmal AF Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Lucas V.A. Boersma
role: Principal Investigator
affiliation: St. Antonius Hospital
facility: 
facility: 
facility: 
country: Hungary
country: Netherlands
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 