<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/NCT03242720</url>
  </required_header>
  <id_info>
    <org_study_id>41798</org_study_id>
    <nct_id>NCT03242720</nct_id>
  </id_info>
  <brief_title>Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients</brief_title>
  <acronym>OSA-AFIB</acronym>
  <official_title>Effects of Positive Airway Pressure on Atrial Fibrillation Recurrence Risk After Catheter Ablation in Patients With Atrial Fibrillation and Obstructive Sleep Apnea-A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      With this pilot study, we are hoping to test the feasibility of a larger study in the future&#xD;
      and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial&#xD;
      fibrillation after successful catheter ablation procedure among patients with atrial&#xD;
      fibrillation and obstructive sleep apnea. The results from this study will help us refine the&#xD;
      design for a future larger study, and will ultimately improve care of patients with&#xD;
      obstructive sleep apnea and atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for&#xD;
      short periods during sleep, is a common condition in patients with atrial fibrillation.&#xD;
      Studies have shown that up to 75% of atrial fibrillation patients undergoing catheter&#xD;
      ablation procedure have obstructive sleep apnea. Obstructive sleep apnea increases the risk&#xD;
      of atrial fibrillation recurrence after successful catheter ablation by 40%. However, whether&#xD;
      treatment of obstructive sleep apnea with positive airway pressure (PAP, the current most&#xD;
      effective treatment for obstructive sleep apnea that uses a machine to help breathe more&#xD;
      easily) reduces the risk of atrial fibrillation recurrence is not fully understood. The&#xD;
      purpose of this study, therefore, is to examine whether positive airway pressure therapy&#xD;
      reduces atrial fibrillation recurrence after catheter ablation in patients with obstructive&#xD;
      sleep apnea and atrial fibrillation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding issues&#xD;
  </why_stopped>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Atrial Fibrillation recurrence</measure>
    <time_frame>6 months after ablation</time_frame>
    <description>Risk of Atrial Fibrillation recurrence</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Active Positive Airway Pressure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active positive airway pressure for treatment of Obstructive Sleep Apnea</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Positive Airway Pressure</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham positive airway pressure for treatment of Obstructive Sleep Apnea</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac Ablation for Atrial Fibrillation</intervention_name>
    <description>Ablation of arrhythmia focus in the heart for atrial fibrillation</description>
    <arm_group_label>Active Positive Airway Pressure</arm_group_label>
    <arm_group_label>Sham Positive Airway Pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women 18 years or older&#xD;
&#xD;
          2. First-time catheter ablation for atrial fibrillation&#xD;
&#xD;
          3. Moderate-to-severe obstructive sleep apnea diagnosed with a sleep study&#xD;
             (apnea-hypopnea index ≥ 15)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or prior use of positive airway pressure for obstructive sleep apnea&#xD;
&#xD;
          2. Any household member with current/past positive airway pressure use&#xD;
&#xD;
          3. Did not meet minimal adherence to positive airway pressure treatment (≥ 4 hours/night&#xD;
             and ≥ 70% of time in 2 weeks)&#xD;
&#xD;
          4. History of motor vehicle or occupational accident related to excessive sleepiness&#xD;
&#xD;
          5. Severe nocturnal desaturation documented on sleep study as &gt;10% of total sleep time&#xD;
             with oxygen saturation of &lt; 75%&#xD;
&#xD;
          6. Any condition determined by physicians that constrains the use of positive airway&#xD;
             pressure such as anatomically fixed nasal obstruction, neurological impairment, and&#xD;
             significant claustrophobia.&#xD;
&#xD;
          7. Congestive heart failure (New York Heart Association IV)&#xD;
&#xD;
          8. Severe valvular disease&#xD;
&#xD;
          9. Planned coronary revascularization procedure in the next 6 months&#xD;
&#xD;
         10. Severe pulmonary disease&#xD;
&#xD;
         11. Participation in another treatment intervention trial that might influence results of&#xD;
             this trial&#xD;
&#xD;
         12. Ablation procedure scheduled in the next 8 weeks&#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>Clete A Kushida, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford Sleep Medicine Center</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>May 17, 2022</last_update_submitted>
  <last_update_submitted_qc>May 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Clete A. Kushida</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Recurrence</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/NCT03242720
org study id: 41798
nct id: NCT03242720
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
With this pilot study, we are hoping to test the feasibility of a larger study in the future
      and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial
      fibrillation after successful catheter ablation procedure among patients with atrial
      fibrillation and obstructive sleep apnea. The results from this study will help us refine the
      design for a future larger study, and will ultimately improve care of patients with
      obstructive sleep apnea and atrial fibrillation.
Obstructive sleep apnea, a sleep-related breathing disorder in which breathing stops for
      short periods during sleep, is a common condition in patients with atrial fibrillation.
      Studies have shown that up to 75% of atrial fibrillation patients undergoing catheter
      ablation procedure have obstructive sleep apnea. Obstructive sleep apnea increases the risk
      of atrial fibrillation recurrence after successful catheter ablation by 40%. However, whether
      treatment of obstructive sleep apnea with positive airway pressure (PAP, the current most
      effective treatment for obstructive sleep apnea that uses a machine to help breathe more
      easily) reduces the risk of atrial fibrillation recurrence is not fully understood. The
      purpose of this study, therefore, is to examine whether positive airway pressure therapy
      reduces atrial fibrillation recurrence after catheter ablation in patients with obstructive
      sleep apnea and atrial fibrillation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Atrial Fibrillation recurrence
time frame: 6 months after ablation
description: Risk of Atrial Fibrillation recurrence
arm group label: Active Positive Airway Pressure
arm group type: Active Comparator
description: Active positive airway pressure for treatment of Obstructive Sleep Apnea
arm group label: Sham Positive Airway Pressure
arm group type: Sham Comparator
description: Sham positive airway pressure for treatment of Obstructive Sleep Apnea
intervention type: Procedure
intervention name: Cardiac Ablation for Atrial Fibrillation
description: Ablation of arrhythmia focus in the heart for atrial fibrillation
arm group label: Active Positive Airway Pressure
arm group label: Sham Positive Airway Pressure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clete A Kushida, MD, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Clete A. Kushida
investigator title: Professor
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Atrial Fibrillation
mesh term: Recurrence
sharing ipd: No