<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/NCT03263702</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-1537</org_study_id>
    <nct_id>NCT03263702</nct_id>
  </id_info>
  <brief_title>RADAR Clinical Trial</brief_title>
  <official_title>Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vivek Reddy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AFTx, Inc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, multicenter, observational study will examine the ability of real time&#xD;
      electrogram processing mapping to identify driver domains to target for ablation in&#xD;
      persistent AF patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs)&#xD;
      during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a&#xD;
      novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize&#xD;
      rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left&#xD;
      atrial electroanatomic maps were created from signals recorded from multipolar circular&#xD;
      mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired&#xD;
      patient datasets were of adequate quality for analysis CMA, employing an AF pattern&#xD;
      recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and&#xD;
      rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate&#xD;
      based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and&#xD;
      complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers,&#xD;
      including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were&#xD;
      identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and&#xD;
      30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR.&#xD;
      Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the&#xD;
      time for NSBR (p&lt;0.0001).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2017</start_date>
  <completion_date type="Actual">June 7, 2019</completion_date>
  <primary_completion_date type="Actual">June 7, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Atrial Fibrillation Termination</measure>
    <time_frame>Day 1</time_frame>
    <description>Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Free From Recurrent AT/AF on no AAD</measure>
    <time_frame>at 12 months</time_frame>
    <description>Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Free From Recurrent AT/AF With no or Some AAD</measure>
    <time_frame>at 12 months</time_frame>
    <description>Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Post-ablation Inducibility of AF</measure>
    <time_frame>Day 1</time_frame>
    <description>Post-ablation inducibility of AF (&gt; 5 mins) with burst pacing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of RF Ablation</measure>
    <time_frame>Day 1</time_frame>
    <description>Amount of radiofrequency ablation used for atrial fibrillation ablation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Fluoro Time</measure>
    <time_frame>Day 1</time_frame>
    <description>Duration of fluoroscopy used during the AF ablation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Exposure</measure>
    <time_frame>Day 1</time_frame>
    <description>Radiation exposure due to fluoroscopy during the AF ablation procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Procedure Time</measure>
    <time_frame>Day 1</time_frame>
    <description>Duration of RADAR procedure time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Procedure-related Adverse Events</measure>
    <time_frame>up to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Major Adverse Cardiac Events (MACE)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Serious Adverse Events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Persistent Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Computational Mapping Algorithm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>AF mapping (utilizing CMA) will be performed and used to point the operator to regions within a heart chamber that should be interrogated further for suspicious electrogram activity, as measured by the St. Jude Ensite System, and ablated if the suspicious electrogram activity persists.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Computational Mapping Algorithm</intervention_name>
    <description>This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).</description>
    <arm_group_label>Computational Mapping Algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years of age.&#xD;
&#xD;
          -  Patients are considered eligible if they have symptomatic or drug-refractory AF and&#xD;
             are planned to undergo a catheter ablation procedure for persistent AF (ether a first&#xD;
             procedure or a redo procedure)&#xD;
&#xD;
          -  Ability to understand the requirements of the study and sign the informed consent&#xD;
             form.&#xD;
&#xD;
          -  Willingness to adhere to study restrictions and comply with all post-procedural&#xD;
             follow-up requirements&#xD;
&#xD;
          -  Projected lifespan greater than 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  They have long-standing persistent AF prior to the first procedure (defined as AF&#xD;
             greater than one year's duration).&#xD;
&#xD;
          -  Rheumatic heart disease&#xD;
&#xD;
          -  Current intra-cardiac thrombus&#xD;
&#xD;
          -  History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks&#xD;
&#xD;
          -  Unstable angina&#xD;
&#xD;
          -  CVA or TIA within 3 months&#xD;
&#xD;
          -  Contraindication to anticoagulation&#xD;
&#xD;
          -  Class IV HF&#xD;
&#xD;
          -  Unable to sign consent&#xD;
&#xD;
          -  Projected lifespan of &lt; 1 year&#xD;
&#xD;
          -  Women known to be pregnant or to have positive beta-HCG (Human Chorionic&#xD;
             Gonadotropin).&#xD;
&#xD;
          -  Participation in another study that would interfere with this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vivek Reddy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Medical Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Denver Cardiology</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <results_first_submitted>April 8, 2020</results_first_submitted>
  <results_first_submitted_qc>April 8, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 21, 2020</results_first_posted>
  <last_update_submitted>May 11, 2020</last_update_submitted>
  <last_update_submitted_qc>May 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Vivek Reddy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Persistent Atrial Fibrillation</keyword>
  <keyword>mapping</keyword>
  <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 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>December 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03263702/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>De Novo</title>
          <description>Participants with 1st procedure</description>
        </group>
        <group group_id="P2">
          <title>Re-Do Ablation</title>
          <description>Participants who need a re-do ablation procedure</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>De Novo</title>
          <description>Participants with 1st procedure</description>
        </group>
        <group group_id="B2">
          <title>Re-Do Ablation</title>
          <description>Participants who need a re-do ablation procedure</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="38"/>
            <count group_id="B2" value="26"/>
            <count group_id="B3" value="64"/>
          </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="64.2" spread="9.4"/>
                    <measurement group_id="B2" value="65.4" spread="9.9"/>
                    <measurement group_id="B3" value="64.7" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Atrial Fibrillation Termination</title>
        <description>Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Atrial Fibrillation Termination</title>
          <description>Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Free From Recurrent AT/AF on no AAD</title>
        <description>Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)</description>
        <time_frame>at 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Free From Recurrent AT/AF on no AAD</title>
          <description>Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Free From Recurrent AT/AF With no or Some AAD</title>
        <description>Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs</description>
        <time_frame>at 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Free From Recurrent AT/AF With no or Some AAD</title>
          <description>Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Post-ablation Inducibility of AF</title>
        <description>Post-ablation inducibility of AF (&gt; 5 mins) with burst pacing</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Post-ablation Inducibility of AF</title>
          <description>Post-ablation inducibility of AF (&gt; 5 mins) with burst pacing</description>
          <units>percent of occurences</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of RF Ablation</title>
        <description>Amount of radiofrequency ablation used for atrial fibrillation ablation</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of RF Ablation</title>
          <description>Amount of radiofrequency ablation used for atrial fibrillation ablation</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="323" spread="141.5"/>
                    <measurement group_id="O2" value="316" spread="88.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Fluoro Time</title>
        <description>Duration of fluoroscopy used during the AF ablation procedure</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Fluoro Time</title>
          <description>Duration of fluoroscopy used during the AF ablation procedure</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" spread="13.1"/>
                    <measurement group_id="O2" value="24.1" spread="9.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Exposure</title>
        <description>Radiation exposure due to fluoroscopy during the AF ablation procedure</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Exposure</title>
          <description>Radiation exposure due to fluoroscopy during the AF ablation procedure</description>
          <units>mGy</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245" spread="201"/>
                    <measurement group_id="O2" value="241" spread="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Procedure Time</title>
        <description>Duration of RADAR procedure time</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Procedure Time</title>
          <description>Duration of RADAR procedure time</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.6" spread="20.3"/>
                    <measurement group_id="O2" value="34.5" spread="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Procedure-related Adverse Events</title>
        <time_frame>up to 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Procedure-related Adverse Events</title>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Major Adverse Cardiac Events (MACE)</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Major Adverse Cardiac Events (MACE)</title>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Serious Adverse Events</title>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>De Novo</title>
            <description>Participants with 1st procedure</description>
          </group>
          <group group_id="O2">
            <title>Re-Do Ablation</title>
            <description>Participants who need a re-do ablation procedure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Serious Adverse Events</title>
          <units>events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>De Novo</title>
          <description>Participants with 1st procedure</description>
        </group>
        <group group_id="E2">
          <title>Re-Do Ablation</title>
          <description>Participants who need a re-do ablation procedure</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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Non-sustained Ventricular Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Severe Mitral Valve Regurgitation, and Paroxysmal Atrial Fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Severe three vessel coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Worsening heart failure with influenza</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Blood in stool</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gastroesophageal bleed with hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper GI bleed</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Amiodarone Intolerance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Generalized Weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Shortness of breath and abdominal rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amiodarone induced ataxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Prostatectomy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <description>lung infection</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>COPD Exacebation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cellulitis with lower back abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Pseudoaneurysm of right femoral artery</sub_title>
                <description>with retroperitoneal hemorrhage</description>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </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="8" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Congestive Heart Failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Atypical flutter with RVR</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fluid Overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Peripheral Edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Recurrent Left Pleural Effusions</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Symptomatic PVCs</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>VF with ICD Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo (Labyrinthitis)</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cogitive Decline</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Lower extremity edema</sub_title>
                <description>lower extremity edema with dyspnea and subsequent hypokalemia with diuresis</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="26"/>
              </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>Sam Cammack</name_or_title>
      <organization>Icahn School of Medicine at Mount Sinai</organization>
      <phone>212-824-8931</phone>
      <email>sam.cammack@mountsinai.org</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/NCT03263702
org study id: GCO 17-1537
nct id: NCT03263702
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
This prospective, multicenter, observational study will examine the ability of real time
      electrogram processing mapping to identify driver domains to target for ablation in
      persistent AF patients.
ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs)
      during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a
      novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize
      rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left
      atrial electroanatomic maps were created from signals recorded from multipolar circular
      mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired
      patient datasets were of adequate quality for analysis CMA, employing an AF pattern
      recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and
      rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate
      based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and
      complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers,
      including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were
      identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and
      30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR.
      Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the
      time for NSBR (p<0.0001).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Number of Participants With Atrial Fibrillation Termination
time frame: Day 1
description: Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)
measure: Number of Participants Free From Recurrent AT/AF on no AAD
time frame: at 12 months
description: Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)
measure: Number of Participants Free From Recurrent AT/AF With no or Some AAD
time frame: at 12 months
description: Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs
measure: Rate of Post-ablation Inducibility of AF
time frame: Day 1
description: Post-ablation inducibility of AF (> 5 mins) with burst pacing
measure: Duration of RF Ablation
time frame: Day 1
description: Amount of radiofrequency ablation used for atrial fibrillation ablation
measure: Duration of Fluoro Time
time frame: Day 1
description: Duration of fluoroscopy used during the AF ablation procedure
measure: Duration of Exposure
time frame: Day 1
description: Radiation exposure due to fluoroscopy during the AF ablation procedure
measure: Duration of Procedure Time
time frame: Day 1
description: Duration of RADAR procedure time
measure: Number of Procedure-related Adverse Events
time frame: up to 12 months
measure: Number of Major Adverse Cardiac Events (MACE)
time frame: 12 months
measure: Number of Serious Adverse Events
time frame: 12 months
arm group label: Computational Mapping Algorithm
arm group type: Experimental
description: AF mapping (utilizing CMA) will be performed and used to point the operator to regions within a heart chamber that should be interrogated further for suspicious electrogram activity, as measured by the St. Jude Ensite System, and ablated if the suspicious electrogram activity persists.
intervention type: Device
intervention name: Computational Mapping Algorithm
description: This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).
arm group label: Computational Mapping Algorithm
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Vivek Reddy, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
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country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Vivek Reddy
investigator title: Professor
mesh term: Atrial Fibrillation
sharing ipd: No
provided document: 
participant flow: 
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outcome list: 
reported events: 
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point of contact: 