<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/NCT03040661</url>
  </required_header>
  <id_info>
    <org_study_id>16-2381</org_study_id>
    <nct_id>NCT03040661</nct_id>
  </id_info>
  <brief_title>Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture</brief_title>
  <acronym>Figure 8</acronym>
  <official_title>Randomized Trial of Femoral Vein Hemostasis After Ablation for Atrial Fibrillation With Manual Pressure Versus a Figure of 8 Suture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inova Health Care Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inova Health Care Services</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including&#xD;
      a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the&#xD;
      procedure, heparin is administered to maintain a target ACT &gt; 300 seconds. At the conclusion&#xD;
      of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at&#xD;
      least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach,&#xD;
      an ACT is checked and protamine is administered. The ACT is rechecked 20&quot; later, and if &lt; 220&#xD;
      msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual&#xD;
      Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in&#xD;
      each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need&#xD;
      for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time Required to Achieve Hemostasis</measure>
    <time_frame>Time (minutes) from sheath removal till hemostasis achieved</time_frame>
    <description>Time Required to Achieve Hemostasis (minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.</measure>
    <time_frame>Time (minutes) from completion of procedure till patient leaves room</time_frame>
    <description>Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group</measure>
    <time_frame>Assessed after sheath removal till patient discharge</time_frame>
    <description>Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Figure of 8 Suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Hemostasis Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ablation for atrial fibrillation.</intervention_name>
    <description>Ablation for atrial fibrillation.</description>
    <arm_group_label>Figure of 8 Suture</arm_group_label>
    <arm_group_label>Manual Hemostasis Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who meets standard clinical criteria for an ablation of AF with&#xD;
             Cryoballoon, and is to undergo the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients.&#xD;
&#xD;
          2. Age &lt;18 years.&#xD;
&#xD;
          3. Patients who cannot provide consent in English.&#xD;
&#xD;
          4. Prisoners.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Inova Fairfax Hospital</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>December 6, 2019</results_first_submitted>
  <results_first_submitted_qc>December 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 11, 2022</results_first_posted>
  <last_update_submitted>December 23, 2021</last_update_submitted>
  <last_update_submitted_qc>December 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <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>November 2, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03040661/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Figure of 8 Suture</title>
          <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.: Ablation for atrial fibrillation.</description>
        </group>
        <group group_id="P2">
          <title>Manual Hemostasis Group</title>
          <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation.: Ablation for atrial fibrillation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Figure of 8 Suture</title>
          <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.: Ablation for atrial fibrillation.</description>
        </group>
        <group group_id="B2">
          <title>Manual Hemostasis Group</title>
          <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation.: Ablation for atrial fibrillation.</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="35"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="70"/>
          </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="62.1" spread="9.5"/>
                    <measurement group_id="B2" value="62.1" spread="9.4"/>
                    <measurement group_id="B3" value="62.1" 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="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="43"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </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="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="61"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>
                  <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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time Required to Achieve Hemostasis</title>
        <description>Time Required to Achieve Hemostasis (minutes)</description>
        <time_frame>Time (minutes) from sheath removal till hemostasis achieved</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Figure of 8 Suture</title>
            <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.</description>
          </group>
          <group group_id="O2">
            <title>Manual Hemostasis Group</title>
            <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation</description>
          </group>
        </group_list>
        <measure>
          <title>Time Required to Achieve Hemostasis</title>
          <description>Time Required to Achieve Hemostasis (minutes)</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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="15" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.</title>
        <description>Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)</description>
        <time_frame>Time (minutes) from completion of procedure till patient leaves room</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Figure of 8 Suture</title>
            <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.</description>
          </group>
          <group group_id="O2">
            <title>Manual Hemostasis Group</title>
            <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation</description>
          </group>
        </group_list>
        <measure>
          <title>Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.</title>
          <description>Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)</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="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="5"/>
                    <measurement group_id="O2" value="28" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group</title>
        <description>Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.</description>
        <time_frame>Assessed after sheath removal till patient discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Figure of 8 Suture</title>
            <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.</description>
          </group>
          <group group_id="O2">
            <title>Manual Hemostasis Group</title>
            <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group</title>
          <description>Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.</description>
          <units>percent</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="34.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>In-hospital and 30 days post procedure</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Figure of 8 Suture</title>
          <description>Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.&#xD;
Ablation for atrial fibrillation.</description>
        </group>
        <group group_id="E2">
          <title>Manual Hemostasis Group</title>
          <description>Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.&#xD;
Ablation for atrial fibrillation</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hematoma or minor bleeding at site</sub_title>
                <counts group_id="E1" events="35" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="35" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Vineet Kumar</name_or_title>
      <organization>Inova Heart and Vascular Institute</organization>
      <phone>(703) 289-9400</phone>
      <email>vineet.kumar@inova.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/NCT03040661
org study id: 16-2381
nct id: NCT03040661
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Patients who undergo ablation for AF typically have 2 sheaths placed in each groin, including
      a large sheath when the Cryo Balloon is used for pulmonary vein isolation. During the
      procedure, heparin is administered to maintain a target ACT > 300 seconds. At the conclusion
      of the procedure, the venous sheaths are removed and hemostasis is obtained. There are at
      least 2 ways of obtaining hemostasis after venous access. In the manual hemostasis approach,
      an ACT is checked and protamine is administered. The ACT is rechecked 20" later, and if < 220
      msec, the sheaths are pulled and hemostasis is achieved with manual pressure (Manual
      Hemostasis Group). Another approach is to place a Figure of 8 suture around the sheaths in
      each groin to achieve hemostasis as the sheaths are removed, and therefore obviate the need
      for assessment of the ACT, protamine administration, and manual pressure (Figure of 8 Group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time Required to Achieve Hemostasis
time frame: Time (minutes) from sheath removal till hemostasis achieved
description: Time Required to Achieve Hemostasis (minutes)
measure: Time Required From the Completion of the Ablation Portion of the Procedure Until the Patient Leaves the EP Lab.
time frame: Time (minutes) from completion of procedure till patient leaves room
description: Time required from the completion of the ablation portion of the procedure until the patient leaves the EP Lab (minutes)
measure: Percent Groin Complications in Figure of 8 Suture Technique Group Compared to Manual Hemostasis Group
time frame: Assessed after sheath removal till patient discharge
description: Percent groin complications ( major or minor bleeding, additional pressure required for hemostasis, hematoma, pseudoaneurysm, and transfusion) in Figure of 8 suture technique group compared to manual hemostasis group.
arm group label: Figure of 8 Suture
arm group type: Experimental
description: Hemostasis after an ablation for atrial fibrillation with a figure of 8 suture.
arm group label: Manual Hemostasis Group
arm group type: Active Comparator
description: Hemostasis after an ablation for atrial fibrillation with the Manual Hemostasis Technique.
intervention type: Procedure
intervention name: Ablation for atrial fibrillation.
description: Ablation for atrial fibrillation.
arm group label: Figure of 8 Suture
arm group label: Manual Hemostasis Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 