<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/NCT01710150</url>
  </required_header>
  <id_info>
    <org_study_id>REDUCE AF</org_study_id>
    <nct_id>NCT01710150</nct_id>
  </id_info>
  <brief_title>Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter</brief_title>
  <acronym>REDUCE AF</acronym>
  <official_title>Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to compare long term occurrence of atrial arrhythmias including atrial&#xD;
      fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in&#xD;
      patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation&#xD;
      alone versus CTI ablation combined with pulmonary vein isolation (PVI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the&#xD;
      safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long&#xD;
      term freedom from typical AFLT has been consistently shown after successful ablation, but up&#xD;
      to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial&#xD;
      Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the&#xD;
      heart (left atrium - LA). These triggers typically arise from in and around the opening of&#xD;
      the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The&#xD;
      highest incidence of AF in patients undergoing ablation for typical AFLT was observed where&#xD;
      the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF&#xD;
      development in patients undergoing typical AFLT ablation is progressive and inevitable.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic &gt;70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation.</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Typical Atrial Flutter</condition>
  <condition>Risk Factors With Future Development of Atrial Flutter</condition>
  <arm_group>
    <arm_group_label>CTI ablation only</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTI ablation and PVI.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CTI ablation alone</intervention_name>
    <arm_group_label>CTI ablation only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CTI ablation and Pulmonary vein isolation (PVI)</intervention_name>
    <arm_group_label>CTI ablation and PVI.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation&#xD;
        and manifest ≥ 2 risk factors associated with future development of AF will be eligible to&#xD;
        participate in the study.&#xD;
&#xD;
        Risk factors for predicting future occurrence of AF will include:&#xD;
&#xD;
          1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for&#xD;
             study participation),&#xD;
&#xD;
          2. LA size &gt; 4.0 cm,&#xD;
&#xD;
          3. left ventricular ejection fraction (LVEF) ≤ 50%,&#xD;
&#xD;
          4. hypertension, and/or 5) obstructive sleep apnea.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,&#xD;
&#xD;
          2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure&#xD;
             and&#xD;
&#xD;
          3. failure to provide informed consent.&#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>Sanjay Dixit, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 18, 2012</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>typical aflutter (AFLT)</keyword>
  <keyword>CTI ablation</keyword>
  <keyword>Atrial Fibrillation (AF)</keyword>
  <keyword>PVI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Atrial Flutter</mesh_term>
  </condition_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/NCT01710150
org study id: REDUCE AF
nct id: NCT01710150
lead sponsor: 
has dmc: Yes
The purpose is to compare long term occurrence of atrial arrhythmias including atrial
      fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in
      patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation
      alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the
      safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long
      term freedom from typical AFLT has been consistently shown after successful ablation, but up
      to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial
      Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the
      heart (left atrium - LA). These triggers typically arise from in and around the opening of
      the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The
      highest incidence of AF in patients undergoing ablation for typical AFLT was observed where
      the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF
      development in patients undergoing typical AFLT ablation is progressive and inevitable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).
time frame: 2 years
measure: Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death
time frame: 2 years
measure: Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation.
time frame: 2 years
arm group label: CTI ablation only
arm group type: Placebo Comparator
description: subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
arm group label: CTI ablation and PVI.
arm group type: Active Comparator
description: subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
intervention type: Procedure
intervention name: CTI ablation alone
arm group label: CTI ablation only
intervention type: Procedure
intervention name: CTI ablation and Pulmonary vein isolation (PVI)
arm group label: CTI ablation and PVI.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sanjay Dixit, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation
mesh term: Atrial Flutter