<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/NCT03232645</url>
  </required_header>
  <id_info>
    <org_study_id>PM007</org_study_id>
    <nct_id>NCT03232645</nct_id>
  </id_info>
  <brief_title>Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation</brief_title>
  <acronym>LOCALIZE</acronym>
  <official_title>ELectrical COupling Information From The Rhythmia HDx Mapping System And DireCtSense Technology In The Treatment Of Paroxysmal AtriaL FibrIllation- A Non-RandomiZed, ProspEctive Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to collect data on the use of the Rhythmia HDx mapping system&#xD;
      running commercially available Software Version 2.0 or any future commercially available&#xD;
      Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in&#xD;
      patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF).&#xD;
      The study will collect specific information to characterize the DirectSense technology in&#xD;
      subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a&#xD;
      commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in&#xD;
      order to generate usage guidance on the DirectSense local impedance feature in the management&#xD;
      of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop&#xD;
      a future lesion indexing feature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">August 5, 2020</completion_date>
  <primary_completion_date type="Actual">June 23, 2020</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>Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment</measure>
    <time_frame>Day 0 and 3 months</time_frame>
    <description>Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure.&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local Impedance and Local Impedance Change and PVI Gaps at Day Zero</measure>
    <time_frame>Day 0</time_frame>
    <description>Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0).&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Gaps at Day Zero</measure>
    <time_frame>Day 0</time_frame>
    <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Local Impedance and Local Impedance Change at Day Zero</measure>
    <time_frame>Day 0</time_frame>
    <description>Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Number of Gaps Per PV Segment at Day Zero</measure>
    <time_frame>Day 0</time_frame>
    <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Impedance in Segments With Maximum Number of Gaps at Day Zero</measure>
    <time_frame>Day 0</time_frame>
    <description>Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Paroxysmal Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Rhythmia HDx and DirectSense technology</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ablation procedure</intervention_name>
    <description>Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
    <arm_group_label>Rhythmia HDx and DirectSense technology</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • History of recurrent symptomatic PAF with ≥1 episode reported and documented within&#xD;
             the 365 days prior to enrollment; PAF is defined as AF episodes that last ≥30 seconds&#xD;
             in duration and terminate within 7 days.&#xD;
&#xD;
               -  Refractory or intolerant to at least one Beta Blocker, Calcium Channel Blocker,&#xD;
                  Class I OR Class III anti-arrhythmic drug (AAD);&#xD;
&#xD;
               -  Eligible for an ablation procedure with the Rhythmia HDx mapping system (software&#xD;
                  version 2.0 or any future commercially available Software Version), IntellaMap&#xD;
                  Orion mapping catheter and IntellaNav MiFi OI ablation catheter according to&#xD;
                  current international and local guidelines (and future revisions) and per&#xD;
                  physician discretion;&#xD;
&#xD;
               -  Subjects who are willing and capable of providing informed consent;&#xD;
&#xD;
               -  Subjects who are willing and capable of participating in all testing associated&#xD;
                  with this clinical investigation at an approved clinical investigational center;&#xD;
&#xD;
               -  Age 18 to 80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Diagnosed with any of the following heart conditions within 90 days (3 months) prior&#xD;
             to enrollment:&#xD;
&#xD;
               1. New York Heart Association (NYHA) Class III or IV&#xD;
&#xD;
               2. Left ventricular ejection fraction (LVEF) &lt;35%&#xD;
&#xD;
               3. Left atrial (LA) diameter &gt;5.5 cm&#xD;
&#xD;
               4. Unstable angina or ongoing myocardial ischemia (OMI)&#xD;
&#xD;
               5. Transmural myocardial infarction (MI), acute coronary syndrome (ACS),&#xD;
                  percutaneous coronary intervention (PCI), or valve or coronary bypass grafting&#xD;
                  surgery&#xD;
&#xD;
                    -  Active systemic infection or sepsis;&#xD;
&#xD;
                    -  Undergone any left atrial heart ablation procedure, either surgical or&#xD;
                       catheter ablation&#xD;
&#xD;
                    -  Prosthetic or stenotic valves in the chamber where the intended mapping will&#xD;
                       occur, or in the path of the catheter access route&#xD;
&#xD;
                    -  Subject has a Left Atrial Appendage Closure (LAAC) or Percutaneous&#xD;
                       Transcatheter Closure of a Patent Foramen Ovale (PFO)&#xD;
&#xD;
                    -  Subject has persistent or long-standing persistent atrial fibrillation (AF)&#xD;
                       ( &gt;1 AF episodes lasting greater than 7 days, with no episodes having lasted&#xD;
                       greater than 30 days, within the past year)&#xD;
&#xD;
                    -  Life expectancy ≤ 6 months per physician judgment&#xD;
&#xD;
                    -  Subjects who are currently enrolled in another investigational study or&#xD;
                       registry that would directly interfere with the current study, except when&#xD;
                       the subject is participating in a mandatory governmental registry, or a&#xD;
                       purely observational registry with no associated treatments; each instance&#xD;
                       must be brought to the attention of the sponsor to determine eligibility;&#xD;
&#xD;
                    -  The subject is unable or not willing to complete follow-up visits and&#xD;
                       examination for the duration of the study;&#xD;
&#xD;
                    -  Women of childbearing potential who are, or plan to become, pregnant during&#xD;
                       the time of the study (method of assessment upon physician's discretion).&#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>Ignacio Garcia Bolao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinica Universitaria de Navarra</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bruno Reissmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitäres Herzzentrum Hamburg</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Armin Luik, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stadtisches Klinikum Karlsruhe</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pierre Jais, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moloy Das, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Freeman Health System</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Waqas Ullah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitäres Herzzentrum Hamburg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stadtisches Klinikum Karlsruhe</name>
      <address>
        <city>Karlsruhe</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitaria de Navarra</name>
      <address>
        <city>Pamplona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Hospital</name>
      <address>
        <city>Newcastle</city>
        <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>France</country>
    <country>Germany</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>June 14, 2021</results_first_submitted>
  <results_first_submitted_qc>July 15, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 9, 2021</results_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</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>
    <ipd_description>No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 5, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT03232645/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Rhythmia HDx and DirectSense Technology</title>
          <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.&#xD;
Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Rhythmia HDx and DirectSense Technology</title>
          <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="62"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Resting Heart Rate</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>bpm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Systolic Blood pressure</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="61"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="126" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Diastolic Blood Pressure</title>
          <population>62 subjects enrolled, 61 baseline: 1 subject withdrawn consent before baseline. For one additional subject the data was not collected</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment</title>
        <description>Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure.&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
        <time_frame>Day 0 and 3 months</time_frame>
        <population>51 subjects were included in the analysis as 7 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.&#xD;
Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.</description>
          </group>
        </group_list>
        <measure>
          <title>Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment</title>
          <description>Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure.&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
          <population>51 subjects were included in the analysis as 7 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
          <units>ohm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Overall number of Ablations</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Overall number of Ablations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3872"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Local Impedance at Baseline in Pulmonary Veins segments where block was achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.2" lower_limit="96.6" upper_limit="117.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.9" lower_limit="92.8" upper_limit="113.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change in Pulmonary Veins segments where block was achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.6" lower_limit="-27.5" upper_limit="-13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change in Pulmonary Veins segments where block was not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-13.9" lower_limit="-21.5" upper_limit="-8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local Impedance and Local Impedance Change and PVI Gaps at Day Zero</title>
        <description>Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0).&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
        <time_frame>Day 0</time_frame>
        <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Local Impedance and Local Impedance Change and PVI Gaps at Day Zero</title>
          <description>Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0).&#xD;
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.</description>
          <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
          <units>ohm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <units_analyzed>Overall number of Ablations</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Overall number of Ablations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Local Impedance at Baseline in Pulmonary Veins segments where block was achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107" lower_limit="97.5" upper_limit="118.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance at Baseline in Pulmonary Veins segments where block was not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101.1" lower_limit="92.5" upper_limit="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change in Pulmonary Veins segments where block was achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.4" lower_limit="-27.5" upper_limit="-12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change in Pulmonary Veins segments where block was not achieved</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.9" lower_limit="-18" upper_limit="-6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Gaps at Day Zero</title>
        <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.</description>
        <time_frame>Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Gaps at Day Zero</title>
          <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.</description>
          <units>Number of gaps</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of gaps per Left PV pair after initial encircling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of gaps per Right PV pair after initial encircling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Baseline Local Impedance and Local Impedance Change at Day Zero</title>
        <description>Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.</description>
        <time_frame>Day 0</time_frame>
        <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Baseline Local Impedance and Local Impedance Change at Day Zero</title>
          <description>Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.</description>
          <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
          <units>ohm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Overall number of Ablations</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Overall number of Ablations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4224"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline Local Impedance during initial applications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107.9" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline Local Impedance during touch up applications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change during initial applications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.8" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Local Impedance change during touch up applications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-20.2" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Number of Gaps Per PV Segment at Day Zero</title>
        <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.</description>
        <time_frame>Day 0</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Number of Gaps Per PV Segment at Day Zero</title>
          <description>At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.</description>
          <units>Number of gaps</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Maximum # of gaps observed in a left PV pair segment at index procedure = along appendage/LA ridge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Maximum # of gaps observed in a right PV pair segment at index procedure = near LA roof</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local Impedance in Segments With Maximum Number of Gaps at Day Zero</title>
        <description>Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps</description>
        <time_frame>Day 0</time_frame>
        <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Rhythmia HDx and DirectSense Technology</title>
            <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter</description>
          </group>
        </group_list>
        <measure>
          <title>Local Impedance in Segments With Maximum Number of Gaps at Day Zero</title>
          <description>Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps</description>
          <population>55 subjects were included in the analysis as 5 subjects were removed because the electro-anatomical maps were not technically usable per the specific endpoint analysis.</population>
          <units>ohm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Overall number of Ablations</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Overall number of Ablations</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3750"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Average baseline local impedance in left PV segment with maximum gaps = along appendage/LA ridge</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.2" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Average baseline local impedance in right PV segment with maximum gaps = near LA roof</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105.1" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from enrollment to end of follow-up: 4 Months.</time_frame>
      <desc>Reportable Events: All Serious Adverse Events; All Events Leading to Death; All Thromboembolic Events; All Procedure Related AEs; All Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav MiFi OI ablation catheter; Device Related AEs; All Device Deficiencies related to the study devices; Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects previously not defined in the physicians manuals.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rhythmia HDx and DirectSense Technology</title>
          <description>Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.&#xD;
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.&#xD;
Ablation procedure: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter.&#xD;
Each subject undergoing PVI will be followed at index procedure, at pre-discharge visit, at the month 3 assessment and at month 4 follow up. The visit at three months after index procedure will include an invasive evaluation with the Rhythmia Mapping system to evaluate residual conduction gaps after PVI.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Tachycardia/Other SVT (eg AVRT, AVNRT, EAT)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <description>Slow sinus rhythm leading to dizziness</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary</sub_title>
                <description>Pain in the lower stomach, ague, ascites, pleural effusion</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Adverse reaction - Neurological (non-TIA, non-stroke)</sub_title>
                <description>Unresponsiveness and Acute Confusion</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Stroke (ischemic)</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="62"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hemoptosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Left Atrial (type II) Flutter</sub_title>
                <description>Atypical Flutter</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>NSVT (Non Sustained Ventricular Tachycardia)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Pseudoaneurysm</sub_title>
                <description>Radial Artery Pseudoaneurysm</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Visual blurring/disturbances</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </event>
              <event>
                <sub_title>Atrial Flutter, not specified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="62"/>
              </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>Clinical Trial Manager</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>00393421994999</phone>
      <email>alberto.belligoli@bsci.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/NCT03232645
org study id: PM007
nct id: NCT03232645
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system
      running commercially available Software Version 2.0 or any future commercially available
      Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in
      patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF).
      The study will collect specific information to characterize the DirectSense technology in
      subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a
      commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in
      order to generate usage guidance on the DirectSense local impedance feature in the management
      of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop
      a future lesion indexing feature.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Local Impedance and Local Impedance Change at Day Zero and PVI Gaps at the Month 3 Assessment
time frame: Day 0 and 3 months
description: Association between baseline DirectSense data (Local Impedance/Local Impedance change values) per anatomical segment of the Pulmonary Veins at index ablation procedure (Day 0) and the number of ablation gaps per anatomical segment* of the Pulmonary Veins as measured at the month 3 assessment. The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the 3 Month procedure.
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
measure: Local Impedance and Local Impedance Change and PVI Gaps at Day Zero
time frame: Day 0
description: Acute isolation gaps per anatomical segment* as associated with baseline Local Impedance and Local Impedance change values at first pass encircling during the index ablation procedure (Day 0). The outcome is a comparison of local impedance metrics in block versus reconnected segments as assessed at the index procedure (Day 0).
*Each PV pair is divided in 8 segments using tags placed on the left atrium geometry created with the Rhythmia system.
measure: Number of Gaps at Day Zero
time frame: Day 0
description: At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected. The outcome is reported as the mean number of gaps per each PV pair.
measure: Baseline Local Impedance and Local Impedance Change at Day Zero
time frame: Day 0
description: Average baseline local impedance and local impedance change measured at the index procedure (Day 0) for ablations performed during the first encirclement of the PVs and during the touch ups ablations performed after the 20 minute wait period.
measure: Maximum Number of Gaps Per PV Segment at Day Zero
time frame: Day 0
description: At the index procedure (Day 0), a 20-minute waiting period was required prior to assessing isolation with a left atrium map created with the Rhythmia system. Number and location of gaps for each PV per segment were collected.The outcome is reported as the maximum number of gaps identified within segments for each PV pair.
measure: Local Impedance in Segments With Maximum Number of Gaps at Day Zero
time frame: Day 0
description: Local Impedance measured at the index procedure (Day 0) in different anatomical sites of the PV pairs. It is reported the average baseline local impedance in the right and left segments with the maximum number of gaps
arm group label: Rhythmia HDx and DirectSense technology
arm group type: Other
description: Subjects will undergo ablation treatment of the pulmonary veins with the Rhythmia HDx mapping system with DirectSense technology. Subjects indicated for ablation treatment of de-novo PAF will be selected based on the inclusion/exclusion criteria and if deemed to be eligible for participation, will be asked to sign the Informed Consent Form.
For all enrolled subjects who undergo the ablation procedure, the subjects will be treated with the commercial Rhythmia HDx System with commercially available Software Version 2.0 with DirectSense technology (or any commercially available updates that are released during the course of the study); the IntellaMap Orion mapping catheter and the IntellaNav MiFi OI ablation catheter.
intervention type: Device
intervention name: Ablation procedure
description: Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
arm group label: Rhythmia HDx and DirectSense technology
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ignacio Garcia Bolao, MD
role: Principal Investigator
affiliation: Clinica Universitaria de Navarra
last name: Bruno Reissmann, MD
role: Principal Investigator
affiliation: Universitäres Herzzentrum Hamburg
last name: Armin Luik, MD
role: Principal Investigator
affiliation: Stadtisches Klinikum Karlsruhe
last name: Pierre Jais, MD
role: Principal Investigator
affiliation: University Hospital, Bordeaux
last name: Moloy Das, MD
role: Principal Investigator
affiliation: Freeman Health System
last name: Waqas Ullah, MD
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Spain
country: United Kingdom
responsible party type: Sponsor
mesh term: Atrial Fibrillation
sharing ipd: No
ipd description: No requests for study data have been made at this time, however Boston's Scientific's policy on data sharing can be found at http://www.bostonscientific.com/en-US/data-sharing-requests.html
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 