<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/NCT03026413</url>
  </required_header>
  <id_info>
    <org_study_id>NJ01</org_study_id>
    <nct_id>NCT03026413</nct_id>
  </id_info>
  <brief_title>The Comparison Between the PVAM and CPVI for the Patients of PAF</brief_title>
  <acronym>FORCE-PVA</acronym>
  <official_title>The Comparison Between the Pulmonary Vein Antrum Modification by SmartTouch Ablation Catheter With Contact Force Monitoring and Circumferential Pulmonary Vein Isolation by That Without Contact Force Monitoring Plus Lasso Catheter for the Patients of Paroxysmal Atrial Fibrillation: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital with Nanjing Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the efficacy and safety of circumferential pulmonary vein isolation without&#xD;
      contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial&#xD;
      fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single centre, prospective control study. The study will enroll 180 patients with&#xD;
      2:1 grouped.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>any recorded atrial arrhythmias proved by 7-day holter</measure>
    <time_frame>at least 18 months follow up</time_frame>
    <description>sustained at least 30s</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>procedure time</measure>
    <time_frame>time during patient enrollment</time_frame>
    <description>time that the patient spend in the procedure room</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>x ray time</measure>
    <time_frame>time during patient enrollment</time_frame>
    <description>x ray spent during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>adverse event</measure>
    <time_frame>at least 18 months follow up</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Pulmonary Vein Isolation</condition>
  <arm_group>
    <arm_group_label>PVAM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>pulomonary vein antrum modification with contact force monitoring for AF</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pulmonary vein isolation without contact force</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>pulmonary vein antrum modification</intervention_name>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>PVAM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with paroxysmal atrial fibrillation refractory to drugs&#xD;
&#xD;
          -  with consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  LVEF&lt;50%&#xD;
&#xD;
          -  history of cardiac surgery&#xD;
&#xD;
          -  valvular heart disease&#xD;
&#xD;
          -  abnormal thyroid function&#xD;
&#xD;
          -  left atrial thrombus&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/22820056</url>
    <description>an article about the contact force role in ablation for AF</description>
  </link>
  <results_reference>
    <citation>Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.</citation>
    <PMID>23515263</PMID>
  </results_reference>
  <results_reference>
    <citation>Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.</citation>
    <PMID>22820056</PMID>
  </results_reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>July 19, 2018</last_update_submitted>
  <last_update_submitted_qc>July 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital with Nanjing Medical University</investigator_affiliation>
    <investigator_full_name>Minglong Chen</investigator_full_name>
    <investigator_title>Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>pulmonary vein isolation</keyword>
  <keyword>Contact Force</keyword>
  <keyword>antrum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026413
org study id: NJ01
nct id: NCT03026413
lead sponsor: 
has dmc: Yes
To compare the efficacy and safety of circumferential pulmonary vein isolation without
      contact force with the pulmonary vein antrum modification for patients of paroxysmal atrial
      fibrillation.
This is a single centre, prospective control study. The study will enroll 180 patients with
      2:1 grouped.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: any recorded atrial arrhythmias proved by 7-day holter
time frame: at least 18 months follow up
description: sustained at least 30s
measure: procedure time
time frame: time during patient enrollment
description: time that the patient spend in the procedure room
measure: x ray time
time frame: time during patient enrollment
description: x ray spent during the procedure
measure: adverse event
time frame: at least 18 months follow up
arm group label: PVAM
arm group type: Experimental
description: pulomonary vein antrum modification with contact force monitoring for AF
arm group label: Control arm
arm group type: Active Comparator
description: pulmonary vein isolation without contact force
intervention type: Procedure
intervention name: pulmonary vein antrum modification
arm group label: Control arm
arm group label: PVAM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
url: https://www.ncbi.nlm.nih.gov/pubmed/22820056
description: an article about the contact force role in ablation for AF
citation: Neuzil P, Reddy VY, Kautzner J, Petru J, Wichterle D, Shah D, Lambert H, Yulzari A, Wissner E, Kuck KH. Electrical reconnection after pulmonary vein isolation is contingent on contact force during initial treatment: results from the EFFICAS I study. Circ Arrhythm Electrophysiol. 2013 Apr;6(2):327-33. doi: 10.1161/CIRCEP.113.000374. Epub 2013 Mar 20.
PMID: 23515263
citation: Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.
PMID: 22820056
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital with Nanjing Medical University
investigator full name: Minglong Chen
investigator title: Professor and Director of Cardiac EP Vice Director of Dept. of Cardiology
mesh term: Atrial Fibrillation
sharing ipd: No