<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/NCT01696136</url>
  </required_header>
  <id_info>
    <org_study_id>RDC-2010.01</org_study_id>
    <nct_id>NCT01696136</nct_id>
  </id_info>
  <brief_title>Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for Paroxysmal Atrial Fibrillation (PAF)</brief_title>
  <acronym>MYSTIC-PAF</acronym>
  <official_title>Multi-electrode PulmonarY Vein Isolation Versus Single Tip Wide Area Catheter Ablation for PAF a Randomized Multinational Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>L.V.A. Boersma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>R&amp;D Cardiologie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The MYSTIC_PAF trial investigates the differences between treatment with a single-tip&#xD;
      catheter against a multielectrode catheter in cardiac ablation procedures in patients with&#xD;
      paroxysmal atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Freedom of AF</measure>
    <time_frame>Month 3 after intervention</time_frame>
    <description>Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>AF-Ablation with Multi-electrode catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular AF-ablation with a multi-electrode ablation catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AF-Ablation with single-tip electrode</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Regular AF-ablation with a regular single-tip ablation catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cardiac ablation for Atrial Fibrillation</intervention_name>
    <description>Cardiac ablation for Atrial Fibrillation</description>
    <arm_group_label>AF-Ablation with Multi-electrode catheter</arm_group_label>
    <arm_group_label>AF-Ablation with single-tip electrode</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. History of symptomatic paroxysmal atrial fibrillation defined as:&#xD;
&#xD;
               -  Self-terminating AF with episodes lasting no more than seven consecutive days&#xD;
                  before spontaneous conversion back to sinus rhythm&#xD;
&#xD;
               -  Documentation of one or more events with PAF tracings by ECG, event recordings,&#xD;
                  pacemaker strips or monitor rhythm strips within the past year&#xD;
&#xD;
               -  AF symptoms defined as the manifestation of any of the following:&#xD;
&#xD;
                    -  Palpitations&#xD;
&#xD;
                    -  Fatigue&#xD;
&#xD;
                    -  Exertional dyspnea&#xD;
&#xD;
                    -  Effort intolerance&#xD;
&#xD;
          2. Age between 18 and 70&#xD;
&#xD;
          3. Willingness, ability and commitment to participate in baseline and follow-up&#xD;
             evaluations for the full length of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Structural heart disease of clinical significance including:&#xD;
&#xD;
               -  Previous cardiac surgery (excluding CABG)&#xD;
&#xD;
               -  Symptoms of congestive heart failure including, but not limited to, NYHA Class&#xD;
                  III or IV CHF and/or documented ejection fraction &lt; 40% measured by acceptable&#xD;
                  cardiac testing&#xD;
&#xD;
               -  Left atrial diameter of &gt; 50mm as measured in the parasternal long axis on&#xD;
                  transthoracic echocardiogram&#xD;
&#xD;
               -  Stable/unstable angina or ongoing myocardial ischemia&#xD;
&#xD;
               -  Myocardial infarction (MI) within three months of enrollment&#xD;
&#xD;
               -  Aortic or mitral valve disease &gt; Grade II&#xD;
&#xD;
               -  Congenital heart disease (not including ASD or PFO without a right to left shunt)&#xD;
                  where the underlying abnormality increases the risk of an ablative procedure&#xD;
&#xD;
               -  Prior ASD or PFO closure with a device using a percutaneous approach&#xD;
&#xD;
               -  Hypertrophic cardiomyopathy (LV wall thickness &gt; 1.5 cm)&#xD;
&#xD;
               -  Pulmonary hypertension (mean or systolic PA pressure &gt;50mm Hg on Doppler echo&#xD;
&#xD;
          2. Prior ablation for arrhythmias other than AF within the past three months&#xD;
&#xD;
          3. Prior left sided AF ablation&#xD;
&#xD;
          4. Enrollment in any other ongoing arrhythmia study protocol Any ventricular&#xD;
             tachyarrhythmias currently being treated where the arrhythmia or the management may&#xD;
             interfere with this study&#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>St. Antonius Ziekenhuis Nieuwegein</name>
      <address>
        <city>Nieuwegein</city>
        <state>Utrecht</state>
        <zip>3534CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 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>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>R&amp;D Cardiologie</investigator_affiliation>
    <investigator_full_name>L.V.A. Boersma</investigator_full_name>
    <investigator_title>Cardiologist</investigator_title>
  </responsible_party>
  <keyword>Ablation</keyword>
  <keyword>Multi-electrode catheter</keyword>
  <keyword>Single-tip catheter</keyword>
  <keyword>Holter</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</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/NCT01696136
org study id: RDC-2010.01
nct id: NCT01696136
lead sponsor: 
has dmc: No
The MYSTIC_PAF trial investigates the differences between treatment with a single-tip
      catheter against a multielectrode catheter in cardiac ablation procedures in patients with
      paroxysmal atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Freedom of AF
time frame: Month 3 after intervention
description: Is the patient free of Atrial Fibrillation, at month 3 after the ablation intervention, and not taking anti-arrhythmic drugs
arm group label: AF-Ablation with Multi-electrode catheter
arm group type: Active Comparator
description: Regular AF-ablation with a multi-electrode ablation catheter
arm group label: AF-Ablation with single-tip electrode
arm group type: Active Comparator
description: Regular AF-ablation with a regular single-tip ablation catheter
intervention type: Device
intervention name: Cardiac ablation for Atrial Fibrillation
description: Cardiac ablation for Atrial Fibrillation
arm group label: AF-Ablation with Multi-electrode catheter
arm group label: AF-Ablation with single-tip electrode
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: R&D Cardiologie
investigator full name: L.V.A. Boersma
investigator title: Cardiologist
mesh term: Atrial Fibrillation