<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/NCT02243891</url>
  </required_header>
  <id_info>
    <org_study_id>LAAPITUP3</org_study_id>
    <nct_id>NCT02243891</nct_id>
  </id_info>
  <brief_title>AF Ablation With or Without ROX Coupler Study</brief_title>
  <acronym>LAAPITUP3</acronym>
  <official_title>Left Atrial Ablation for Paroxysmal Atrial Fibrillation and Hypertension With Implantable Loop Recorder With or Without ROX Coupler Follow Up Study: The LAAPITUP 3 Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Neil Sulke</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eastbourne General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in&#xD;
      hypertensive subjects is more effective when a ROX coupler is inserted concurrently.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The single blinded, randomised study is planned to commence in October 2014 after obtaining&#xD;
      Research Ethics Committee and NHS Research and Development approval. A target of 20&#xD;
      participants with symptomatic paroxysmal AF will be recruited. All participants will be&#xD;
      blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All&#xD;
      participants will have right and left heart catheterisation prior to AF ablation +/- ROX&#xD;
      coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after&#xD;
      the ablation. The study will take place at Eastbourne District General. The study duration&#xD;
      per patient is 13months. The overall study duration will be 18 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>May 2015</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>Phase 4</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>AF ablation success</measure>
    <time_frame>3 months</time_frame>
    <description>No AF burden detected on implantable loop recorder</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Atrial fibrillation ablation only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ROX Coupler</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atrial fibrillation ablation with concurrent ROX Coupler insertion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Atrial fibrillation ablation</intervention_name>
    <description>Percutaneous catheter ablation for Atrial fibrillation.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>ROX Coupler</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ROX Coupler insertion</intervention_name>
    <description>The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula</description>
    <arm_group_label>ROX Coupler</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptomatic paroxysmal AF suitable for AF ablation.&#xD;
&#xD;
          -  Office Systolic blood pressure ≥ 140 mmHg based on an average of 3 blood pressure&#xD;
             readings&#xD;
&#xD;
          -  Ambulatory Blood Pressure Monitoring (ABPM) daytime average systolic blood pressure&#xD;
             (SBP) ≥ 135 mmHg;&#xD;
&#xD;
          -  Resistant Hypertension: Patients with established hypertension (diagnosed ≥ 12 months&#xD;
             prior to baseline) and is on a guideline based drug regimen at a stable and a fully&#xD;
             tolerated dose, consisting of ≥3 hypertensive medications (including 1 diuretic), or&#xD;
&#xD;
          -  Uncontrolled Hypertension: Patient has drug intolerances to antihypertensive&#xD;
             medications and is unable to take a guideline based drug regimen&#xD;
&#xD;
          -  VO2 peak &gt; 15mls/Kg/min on Cardiopulmonary exercise testing (CPX)&#xD;
&#xD;
          -  Peak RER &gt; 1.0 on Cardiopulmonary exercise testing&#xD;
&#xD;
          -  Age over 18 years old.&#xD;
&#xD;
          -  Informed consent to participate in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary hypertension amenable to conventional therapy&#xD;
&#xD;
          -  Left ventricular systolic dysfunction with EF &lt; 50%&#xD;
&#xD;
          -  E/E' &gt; 15 on transthoracic echocardiography&#xD;
&#xD;
          -  Uncontrolled diabetes.&#xD;
&#xD;
          -  Body Mass Index &gt; 40 kg/m2&#xD;
&#xD;
          -  Contraindicated for treatment with an arteriovenous anastomosis or interventional&#xD;
             vascular procedure&#xD;
&#xD;
          -  Severe chronic kidney disease as indicated by estimated glomerular filtration rate &lt;&#xD;
             30 mL/min/1.73m2 using the MDRD calculation&#xD;
&#xD;
          -  Renal denervation within the last 6 months&#xD;
&#xD;
          -  Significant peripheral arterial and/or venous disease in the lower limbs (including&#xD;
             unprovoked deep vein thrombosis, significant lower extremity edema and/or venous&#xD;
             insufficiency)&#xD;
&#xD;
          -  Current diagnosis of unstable cardiac disease requiring intervention,or significant&#xD;
             history of serious cardiac comorbidity that may affect patient safety or study&#xD;
             outcomes&#xD;
&#xD;
          -  Current diagnosis of severe cerebrovascular disease or stroke within the past year&#xD;
&#xD;
          -  Female patient who is pregnant, breastfeeding or planning to become pregnant; females&#xD;
             of child-bearing potential must have a negative urine pregnancy test prior to&#xD;
             treatment&#xD;
&#xD;
          -  Any known, unresolved history of drug use or alcohol dependency, lacks the ability to&#xD;
             comprehend or follow instructions, or would be unlikely or unable to comply with study&#xD;
             follow-up requirements&#xD;
&#xD;
          -  Scheduled or planned surgery in the next 6 months that may affect patient safety or&#xD;
             study outcomes&#xD;
&#xD;
          -  Concurrent enrollment in another clinical trial without prior approval of ROX Medical,&#xD;
             Inc.&#xD;
&#xD;
          -  Any serious medical condition that may adversely affect the patient's safety, limit&#xD;
             the subject's ability to participate in the study, comply with follow-up requirements&#xD;
             or impact the scientific integrity of the study&#xD;
&#xD;
          -  Intolerant or allergic to all anti-thrombolytic medications including aspirin&#xD;
&#xD;
          -  Pulmonary arterial hypertension (PAH) defined as mean pulmonary artery pressure (mPAP)&#xD;
             &gt;30 mmHg as measured by right heart catheterization&#xD;
&#xD;
          -  Pulmonary capillary wedge pressure (PCWP) &gt; 15mmHg as measured by right heart&#xD;
             catheterization&#xD;
&#xD;
          -  Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring&#xD;
             for AF occurrence.&#xD;
&#xD;
          -  Participation in a conflicting study.&#xD;
&#xD;
          -  Potential participants who are mentally incapacitated and cannot consent or comply&#xD;
             with follow-up.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Other cardiac rhythm disorders.&#xD;
&#xD;
          -  Severe aortic and mitral valve disease.&#xD;
&#xD;
          -  Previous ROX coupler implantation.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neil Sulke, DM</last_name>
    <role>Principal Investigator</role>
    <affiliation>East Sussex healthcare NHS trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ragunath Shunmugam, M.B,B.S</last_name>
    <phone>+441323417400</phone>
    <phone_ext>4132</phone_ext>
    <email>r.shunmugam@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Eastbourne District General Hospital</name>
      <address>
        <city>Eastbourne</city>
        <state>East Sussex</state>
        <zip>BN21 2UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>March 8, 2015</last_update_submitted>
  <last_update_submitted_qc>March 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Eastbourne General Hospital</investigator_affiliation>
    <investigator_full_name>Neil Sulke</investigator_full_name>
    <investigator_title>Consultant Cardiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <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/NCT02243891
org study id: LAAPITUP3
nct id: NCT02243891
lead sponsor: 
has dmc: No
The study will test the hypothesis that ablation of paroxysmal atrial fibrillation in
      hypertensive subjects is more effective when a ROX coupler is inserted concurrently.
The single blinded, randomised study is planned to commence in October 2014 after obtaining
      Research Ethics Committee and NHS Research and Development approval. A target of 20
      participants with symptomatic paroxysmal AF will be recruited. All participants will be
      blinded and randomised to AF ablation only or AF ablation + ROX coupler implant. All
      participants will have right and left heart catheterisation prior to AF ablation +/- ROX
      coupler insertion. Participants will be followed up 6 weeks, 3, 6 months and 12 months after
      the ablation. The study will take place at Eastbourne District General. The study duration
      per patient is 13months. The overall study duration will be 18 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: AF ablation success
time frame: 3 months
description: No AF burden detected on implantable loop recorder
arm group label: Control
arm group type: Active Comparator
description: Atrial fibrillation ablation only
arm group label: ROX Coupler
arm group type: Experimental
description: Atrial fibrillation ablation with concurrent ROX Coupler insertion
intervention type: Procedure
intervention name: Atrial fibrillation ablation
description: Percutaneous catheter ablation for Atrial fibrillation.
arm group label: Control
arm group label: ROX Coupler
intervention type: Procedure
intervention name: ROX Coupler insertion
description: The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
arm group label: ROX Coupler
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Neil Sulke, DM
role: Principal Investigator
affiliation: East Sussex healthcare NHS trust
last name: Ragunath Shunmugam, M.B,B.S
phone: +441323417400
phone ext: 4132
email: r.shunmugam@nhs.net
facility: 
country: United Kingdom
responsible party type: Sponsor-Investigator
investigator affiliation: Eastbourne General Hospital
investigator full name: Neil Sulke
investigator title: Consultant Cardiologist
mesh term: Hypertension
mesh term: Atrial Fibrillation