<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/NCT01695824</url>
  </required_header>
  <id_info>
    <org_study_id>WA-PR-AF</org_study_id>
    <nct_id>NCT01695824</nct_id>
  </id_info>
  <brief_title>Left Atrial Appendage (LAA) Occluders After Catheter Ablation of Atrial Fibrillation</brief_title>
  <official_title>Implantation of Left Atrial Appendage Occluders Concomitantly With Catheter Ablation in Patients With Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meshalkin Research Institute of Pathology of Circulation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meshalkin Research Institute of Pathology of Circulation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to assess combined end point (All stroke, Systemic&#xD;
      embolism, Cardiovascular death) between two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>All stroke</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic embolism</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cardiovascular death</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure success</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30 day major adverse event (MAE)</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Left atrial appendage (LAA) coverage</measure>
    <time_frame>45 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">96</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>LAA occluder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Warfarin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LAA occluder</intervention_name>
    <description>The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.</description>
    <arm_group_label>LAA occluder</arm_group_label>
    <other_name>Watchman</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>RFA ablation</intervention_name>
    <description>The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by &gt;80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.</description>
    <arm_group_label>LAA occluder</arm_group_label>
    <arm_group_label>Warfarin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Warfarin</intervention_name>
    <description>Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for &quot;Watchman group&quot;&#xD;
All patients in &quot;Warfarin group&quot; continued to receive Warfarin during hole study period with IMR from II to III.</description>
    <arm_group_label>LAA occluder</arm_group_label>
    <arm_group_label>Warfarin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has paroxysmal, persistent or permanent non-valvular atrial fibrillation (AF)&#xD;
&#xD;
          -  Eligible for long term warfarin&#xD;
&#xD;
          -  CHADS score &gt;= 1 (congestive heart failure [CHF], history of high blood pressure, 75&#xD;
             years of age or older, diabetes, prior stroke or transient ischemic attack [TIA])&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindicated for warfarin&#xD;
&#xD;
          -  Contraindicated for aspirin or clopidogrel (Plavix)&#xD;
&#xD;
          -  CHF Class 4&#xD;
&#xD;
          -  Implanted mechanical valve&#xD;
&#xD;
          -  Atrial septal or Patent Foramen Ovale (PFO) device&#xD;
&#xD;
          -  Platelets &lt; 100,000 or hemoglobin &lt; 10&#xD;
&#xD;
          -  Left ventricular ejection fraction (LVEF) &lt; 30%&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Evgeny Pokushalov, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>State Research Institute of Circulation Pathology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>State Research Institute of CIrculation Pathology</name>
      <address>
        <city>Novosibirsk</city>
        <zip>630055</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://meshalkin.ru</url>
    <description>State Research Institute of Circulation Pathology Official Site</description>
  </link>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>July 7, 2015</last_update_submitted>
  <last_update_submitted_qc>July 7, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>catheter ablation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Warfarin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01695824
org study id: WA-PR-AF
nct id: NCT01695824
lead sponsor: 
has dmc: Yes
The primary objective of this study is to assess combined end point (All stroke, Systemic
      embolism, Cardiovascular death) between two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: All stroke
time frame: 12 months
measure: Systemic embolism
time frame: 12 months
measure: Cardiovascular death
time frame: 12 months
measure: Technical success
time frame: 45 days
measure: Procedure success
time frame: 45 days
measure: 30 day major adverse event (MAE)
time frame: 30 days
measure: Left atrial appendage (LAA) coverage
time frame: 45 days
arm group label: LAA occluder
arm group type: Active Comparator
arm group label: Warfarin
arm group type: Active Comparator
intervention type: Device
intervention name: LAA occluder
description: The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.
arm group label: LAA occluder
other name: Watchman
intervention type: Procedure
intervention name: RFA ablation
description: The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.
arm group label: LAA occluder
arm group label: Warfarin
intervention type: Drug
intervention name: Warfarin
description: Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for "Watchman group"
All patients in "Warfarin group" continued to receive Warfarin during hole study period with IMR from II to III.
arm group label: LAA occluder
arm group label: Warfarin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Evgeny Pokushalov, MD, PhD
role: Principal Investigator
affiliation: State Research Institute of Circulation Pathology
facility: 
country: Russian Federation
url: http://meshalkin.ru
description: State Research Institute of Circulation Pathology Official Site
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Warfarin