<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/NCT01716663</url>
  </required_header>
  <id_info>
    <org_study_id>IUAF</org_study_id>
    <nct_id>NCT01716663</nct_id>
  </id_info>
  <brief_title>CARTO® 3 System and Real Time Intracardiac Ultrasound</brief_title>
  <acronym>IUAF</acronym>
  <official_title>CARTO® 3 System and Real Time Intracardiac Ultrasound for Ablation of Drug Refractory Recurrent Symptomatic Paroxysmal AF: Acute Procedural Outcomes Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosense Webster, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosense Webster, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, multicenter, non-randomized observational study of subjects 18 years&#xD;
      and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial&#xD;
      Fibrillation (AF).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is purposed to measure &quot;real world&quot; acute procedural outcomes (procedural&#xD;
      efficiency and acute safety) associated with use of the CARTO® 3 System and real time&#xD;
      intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent&#xD;
      symptomatic paroxysmal AF.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total Fluoroscopy Time</measure>
    <time_frame>Day 0</time_frame>
    <description>The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Procedure Time</measure>
    <time_frame>Day 0</time_frame>
    <description>The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Procedural Success</measure>
    <time_frame>Day 0</time_frame>
    <description>Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Number of Radiofrequency (RF) Applications</measure>
    <time_frame>Day 0</time_frame>
    <description>RF application is defined as the number of times RF energy is delivered during the procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Radiofrequency (RF) Time</measure>
    <time_frame>Day 0</time_frame>
    <description>Total RF time is defined as the total time RF is delivered during the procedure.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">234</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Paroxysmal AF</condition>
  <arm_group>
    <arm_group_label>Experimental: Catheter Ablation</arm_group_label>
    <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Catheter Ablation</intervention_name>
    <description>NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
    <arm_group_label>Experimental: Catheter Ablation</arm_group_label>
    <other_name>CARTO® 3 System and Real Time Intracardiac Ultrasound</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects 18 years and older with drug refractory recurrent symptomatic paroxysmal AF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Drug refractory, recurrent symptomatic paroxysmal AF&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Patients able and willing to provide written informed consent to participate in the&#xD;
             study and comply with study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible&#xD;
             or non-cardiac cause&#xD;
&#xD;
          -  Previous ablation for atrial fibrillation&#xD;
&#xD;
          -  AF episodes that last longer than 30 days&#xD;
&#xD;
          -  Uncontrolled heart failure, or NYHA Class III or IV heart failure&#xD;
&#xD;
          -  Documented intra-atrial thrombus or other abnormality on pre-ablation imaging&#xD;
&#xD;
          -  Contraindication to anticoagulation&#xD;
&#xD;
          -  Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous&#xD;
             coronary intervention within the past 3 months&#xD;
&#xD;
          -  Awaiting cardiac transplantation&#xD;
&#xD;
          -  Heart disease for which corrective surgery is anticipated within 6 months&#xD;
&#xD;
          -  Enrollment in other investigational drug or device study&#xD;
&#xD;
          -  Subjects unwilling to comply with protocol or follow-up requirements&#xD;
&#xD;
          -  Patients who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Usman Siddiqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Osceola Regional Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mathew Hutchinson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Andy Tran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scottsdale Healthcare Research</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Saumil Oza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Fishel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>JFK Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vijendra Swarup, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AZ Heart Rhythm Research Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohit Rastogi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington Adventist Hospital CCVR</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brett Gidney, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Santa Barbara Cottage Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Scherschel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nebraska</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dilip Mathew, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pepin Heart Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Sauer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcie Berger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical College of Wisconsin</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khawaja Baig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kettering Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Farhat Khairallah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tallahassee Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Fitzgerald, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Scott &amp; White Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gopi Dandamudi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ahmad Abdul-Karim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Provena St. Joseph Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Douglas Esberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Main Line Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Burke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Mary Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gregory Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wellmont CVA Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tapan Rami, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Methodist Hospital Research Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Salem Sayar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northeast Georgia Heart Center, PC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gunjan Shukla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hackensack Meridian Health</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Philip Gentlesk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sentara Norfolk General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Asim Yunus, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Michigan CardioVascular Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott Reich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northeast Baptist Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AZ Heart Rhythm Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85013</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scottsdale Healthcare Research Institute</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santa Barbara Cottage Hospital</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Denver</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>JFK Medical Center</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Coast Institute for Research, LLC. St. Vincent's Ambulatory Care, Inc.</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>33204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osceola Regional Medical Center</name>
      <address>
        <city>Kissimmee</city>
        <state>Florida</state>
        <zip>34741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepin Heart Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Heart Center, PC</name>
      <address>
        <city>Gainsville</city>
        <state>Georgia</state>
        <zip>30501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Provena St. Joseph Medical Center</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Adventist Hospital CCVR</name>
      <address>
        <city>Takoma Park</city>
        <state>Maryland</state>
        <zip>20912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan CardioVascular Institute</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Nebraska Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68198</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary Medical Center</name>
      <address>
        <city>Newtown</city>
        <state>Pennsylvania</state>
        <zip>18940</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital of the University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Heart Institute</name>
      <address>
        <city>Wilkes-Barre</city>
        <state>Pennsylvania</state>
        <zip>18711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Institute for Medical Research</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellmont CVA Heart Institute</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Methodist Hospital Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Baptist Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Scott &amp; White Memorial Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Norfolk General Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>November 24, 2014</results_first_submitted>
  <results_first_submitted_qc>November 24, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 1, 2014</results_first_posted>
  <last_update_submitted>November 24, 2014</last_update_submitted>
  <last_update_submitted_qc>November 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Symptomatic paroxysmal</keyword>
  <keyword>Atrial fibrillation</keyword>
  <keyword>Observational</keyword>
  <keyword>Acute procedural outcomes</keyword>
  <keyword>Ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Catheter Ablation</title>
          <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="234">Enrolled = signed informed consent and met eligibility requirements</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety</title>
              <participants_list>
                <participants group_id="P1" count="230">Enrolled patients who had a study device inserted.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="228">Effectiveness population = enrolled and treated (study device inserted and RF energy applied)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawn prior to procedure</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Treated with non-study catheter</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled</population>
      <group_list>
        <group group_id="B1">
          <title>Experimental: Catheter Ablation</title>
          <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="234"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="62.1" spread="11.6"/>
                  </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="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="140"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="230"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Fluoroscopy Time</title>
        <description>The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
        <time_frame>Day 0</time_frame>
        <population>Those patients with non-missing fluoroscopy time.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Catheter Ablation</title>
            <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Fluoroscopy Time</title>
          <description>The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
          <population>Those patients with non-missing fluoroscopy time.</population>
          <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="221"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" spread="29.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Procedure Time</title>
        <description>The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
        <time_frame>Day 0</time_frame>
        <population>The number of patients with non-missing procedure time data.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Catheter Ablation</title>
            <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Procedure Time</title>
          <description>The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.</description>
          <population>The number of patients with non-missing procedure time data.</population>
          <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="225"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150.2" spread="76.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Procedural Success</title>
        <description>Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.</description>
        <time_frame>Day 0</time_frame>
        <population>Acute effectiveness and efficiency cohort</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Catheter Ablation</title>
            <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Procedural Success</title>
          <description>Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.</description>
          <population>Acute effectiveness and efficiency cohort</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Number of Radiofrequency (RF) Applications</title>
        <description>RF application is defined as the number of times RF energy is delivered during the procedure.</description>
        <time_frame>Day 0</time_frame>
        <population>Patients with non-missing RF application values</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Catheter Ablation</title>
            <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Number of Radiofrequency (RF) Applications</title>
          <description>RF application is defined as the number of times RF energy is delivered during the procedure.</description>
          <population>Patients with non-missing RF application values</population>
          <units>number of applications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.2" spread="43.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Radiofrequency (RF) Time</title>
        <description>Total RF time is defined as the total time RF is delivered during the procedure.</description>
        <time_frame>Day 0</time_frame>
        <population>Patients with non-missing RF application time.</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Catheter Ablation</title>
            <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
          </group>
        </group_list>
        <measure>
          <title>Total Radiofrequency (RF) Time</title>
          <description>Total RF time is defined as the total time RF is delivered during the procedure.</description>
          <population>Patients with non-missing RF application time.</population>
          <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="227"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104.7" spread="57.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental: Catheter Ablation</title>
          <description>These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.&#xD;
Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>atrial flutter</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>atrioventricular block</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>pericardial effusion/tamponade</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>puncture site hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>post procedural hematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>cardiac telemetry abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>migraine</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>pulmonary edema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="13" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="230"/>
              </event>
              <event>
                <sub_title>pericarditis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="230"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="230"/>
              </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 an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present, or publish trial results after the trial is completed. Please contact Biosense Webster for additional information.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ellen Harris, Project Manager, Clinical Operations</name_or_title>
      <organization>Biosense Webster</organization>
      <phone>909-839-7376</phone>
      <email>eharris8@its.jnj.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/NCT01716663
org study id: IUAF
nct id: NCT01716663
lead sponsor: 
has dmc: No
This is a prospective, multicenter, non-randomized observational study of subjects 18 years
      and older undergoing RF ablation with drug refractory recurrent symptomatic paroxysmal Atrial
      Fibrillation (AF).
This study is purposed to measure "real world" acute procedural outcomes (procedural
      efficiency and acute safety) associated with use of the CARTO® 3 System and real time
      intracardiac ultrasound in a clinical setting in subjects with drug refractory recurrent
      symptomatic paroxysmal AF.
time perspective: Prospective
measure: Total Fluoroscopy Time
time frame: Day 0
description: The fluoroscopy time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
measure: Total Procedure Time
time frame: Day 0
description: The procedure time will be measured for each phase (access, mapping, ablation, and validation) of the procedure and summed to derive the total.
measure: Acute Procedural Success
time frame: Day 0
description: Acute success will be defined as confirmation of pulmonary vein isolation by entrance block, exit block, and/or periostial block of all targeted pulmonary veins.
measure: Mean Number of Radiofrequency (RF) Applications
time frame: Day 0
description: RF application is defined as the number of times RF energy is delivered during the procedure.
measure: Total Radiofrequency (RF) Time
time frame: Day 0
description: Total RF time is defined as the total time RF is delivered during the procedure.
arm group label: Experimental: Catheter Ablation
description: These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.
intervention type: Device
intervention name: Catheter Ablation
description: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
arm group label: Experimental: Catheter Ablation
other name: CARTO® 3 System and Real Time Intracardiac Ultrasound
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Usman Siddiqui, MD
role: Principal Investigator
affiliation: Osceola Regional Medical Center
last name: Mathew Hutchinson, MD
role: Principal Investigator
affiliation: University of Pennsylvania
last name: Andy Tran, MD
role: Principal Investigator
affiliation: Scottsdale Healthcare Research
last name: Saumil Oza, MD
role: Principal Investigator
affiliation: East Coast Institute for Research LLC, St. Vincent's Ambulatory Care, Inc.
last name: Robert Fishel, MD
role: Principal Investigator
affiliation: JFK Medical Center
last name: Vijendra Swarup, MD
role: Principal Investigator
affiliation: AZ Heart Rhythm Research Center
last name: Mohit Rastogi, MD
role: Principal Investigator
affiliation: Washington Adventist Hospital CCVR
last name: Brett Gidney, MD
role: Principal Investigator
affiliation: Santa Barbara Cottage Hospital
last name: John Scherschel, MD
role: Principal Investigator
affiliation: University of Nebraska
last name: Dilip Mathew, MD
role: Principal Investigator
affiliation: Pepin Heart Hospital
last name: William Sauer, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Marcie Berger, MD
role: Principal Investigator
affiliation: Medical College of Wisconsin
last name: Khawaja Baig, MD
role: Principal Investigator
affiliation: Kettering Medical Center
last name: Farhat Khairallah, MD
role: Principal Investigator
affiliation: Tallahassee Research Institute
last name: David Fitzgerald, MD
role: Principal Investigator
affiliation: Scott & White Memorial Hospital
last name: Gopi Dandamudi, MD
role: Principal Investigator
affiliation: Geisinger Heart Institute
last name: Ahmad Abdul-Karim, MD
role: Principal Investigator
affiliation: Provena St. Joseph Medical Center
last name: Douglas Esberg, MD
role: Principal Investigator
affiliation: Main Line Health
last name: Scott Burke, MD
role: Principal Investigator
affiliation: St. Mary Medical Center
last name: Gregory Jones, MD
role: Principal Investigator
affiliation: Wellmont CVA Heart Institute
last name: Tapan Rami, MD
role: Principal Investigator
affiliation: The Methodist Hospital Research Institute
last name: Salem Sayar, MD
role: Principal Investigator
affiliation: Northeast Georgia Heart Center, PC
last name: Gunjan Shukla, MD
role: Principal Investigator
affiliation: Hackensack Meridian Health
last name: Philip Gentlesk, MD
role: Principal Investigator
affiliation: Sentara Norfolk General Hospital
last name: Asim Yunus, MD
role: Principal Investigator
affiliation: Michigan CardioVascular Institute
last name: Scott Reich, MD
role: Principal Investigator
affiliation: Northeast Baptist Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 