<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/NCT04486339</url>
  </required_header>
  <id_info>
    <org_study_id>XHEC-C-2019-047-4</org_study_id>
    <nct_id>NCT04486339</nct_id>
  </id_info>
  <brief_title>Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation</brief_title>
  <official_title>Pulmonary Vein Isolation Using Stereotactic Radiotherapy System for the Treatment of Refractory Atrial Fibrillation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to investigate the short-term (3 months) and intermediate-term (12 months)&#xD;
      safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to&#xD;
      treat refractory atrial fibrillation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, single arm, prospective and phase 1 clinical trial. Patients with&#xD;
      refractory atrial fibrillation (AF) will receive single fraction stereotactic radiotherapy&#xD;
      for pulmonary vein isolation. To minimize the potential risks associated with this innovative&#xD;
      technique, the study has been designed in a stepwise dose escalation fashion under carefully&#xD;
      observation by the investigators. The dose escalation is guided by 3+3 algorithm to ensure&#xD;
      more patients will be spared dose limiting toxicities and more patients will be entered on&#xD;
      the dose level than will be chosen as optimal dose of maximal effects. Low dosing levels with&#xD;
      established safety profile will first be applied before administering higher dosing levels&#xD;
      based on preclinical studies.&#xD;
&#xD;
      Safety is the primary endpoint of the study. Safety will be assessed by incidence and&#xD;
      evaluation of any serious adverse evens using CTCAE V5.0 criteria associated with the&#xD;
      procedure through 90 days (short-term) and 12 months (intermediate term). Efficacy will be&#xD;
      evaluated by assessing atrial fibrillation recurrence (for paroxysmal AF) or AF burden (for&#xD;
      persistent AF) after 90 days of blank period until 12 months post-treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">November 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>90 days adverse events by CTCA5</measure>
    <time_frame>90 days</time_frame>
    <description>Safety will be assessed by incidence and evaluation of any adverse events using CTCA5 V5.0 criteria that are related to the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>12 months adverse events by CTCA5</measure>
    <time_frame>12 months</time_frame>
    <description>Safety will be assessed by incidence and evaluation of any adverse events using CTCA5 V5.0 criteria that are related to the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of atrial fibrillation (for paroxysmal atrial fibrillation)</measure>
    <time_frame>90 days to 12 months</time_frame>
    <description>Recurrence of atrial fibrillation after 90 days blanking period post-treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atrial fibrillation burden reduction (for persistent atrial fibrillation)</measure>
    <time_frame>90 days to 12 months</time_frame>
    <description>Atrial fibriilation burden reduction after 90 days blanking period post-treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause motality</measure>
    <time_frame>12 months</time_frame>
    <description>Motality due to any reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life improvement</measure>
    <time_frame>3 month, 6 month and 12 month</time_frame>
    <description>Quality of life after the procedure evaluated by the questionnaire</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>stereotactic body radiotherapy (SBRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Noninvasive SBRT will be delivered in a single fraction to electrical isolate the pulmonary veins under CT-guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Radiotherapy</intervention_name>
    <description>Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation</description>
    <arm_group_label>stereotactic body radiotherapy (SBRT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Paroxysmal or persistent atrial fibrillation. Age 55-89 Symptomatic, refractory to at least&#xD;
        3 antiarrhythmic drugs Failure from the previous catheter ablation of atrial fibrillation,&#xD;
        or contraindicate /unwilling to undergo catheter ablation.&#xD;
&#xD;
        Anticoagulation for at least 3 months if CHA2DS2-VASc 2 or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        With concomitant atrial flutter, WPW syndrome or supraventricular tachycardia. With&#xD;
        sustained ventricular tachycardia. With sick sinus syndrome or atrioventricular block&#xD;
        fulfilling the indication of permanent pacemaker implantation.&#xD;
&#xD;
        Stroke or myocardial infarction within 8 weeks. Uncontrolled heart failure or unstable&#xD;
        angina pectoris. Severe structral heart diseases. Severe pulmonary hypertension.&#xD;
        Uncontrolled hypertension. Severe respiratory disease. Esophageal ulcer. Intracardiac&#xD;
        thrombus by TEE. Pregnancy or have a preganancy plan. Others.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi-Gang Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yi-Gang Li</last_name>
    <phone>86-21-25077260</phone>
    <email>liyigang@xinhuamed.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mu Chen</last_name>
    <email>chenmu@xinhuamed.com.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yi-Gang Li, Dr.</last_name>
      <phone>86 021 25077275</phone>
      <email>liyigang@xinhuamed.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yi-Gang Li, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>July 22, 2020</last_update_submitted>
  <last_update_submitted_qc>July 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04486339
org study id: XHEC-C-2019-047-4
nct id: NCT04486339
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study aims to investigate the short-term (3 months) and intermediate-term (12 months)
      safety and preliminary efficacy of stereotactic radiotherapy for pulmonary vein isolation to
      treat refractory atrial fibrillation.
This is a single center, single arm, prospective and phase 1 clinical trial. Patients with
      refractory atrial fibrillation (AF) will receive single fraction stereotactic radiotherapy
      for pulmonary vein isolation. To minimize the potential risks associated with this innovative
      technique, the study has been designed in a stepwise dose escalation fashion under carefully
      observation by the investigators. The dose escalation is guided by 3+3 algorithm to ensure
      more patients will be spared dose limiting toxicities and more patients will be entered on
      the dose level than will be chosen as optimal dose of maximal effects. Low dosing levels with
      established safety profile will first be applied before administering higher dosing levels
      based on preclinical studies.

      Safety is the primary endpoint of the study. Safety will be assessed by incidence and
      evaluation of any serious adverse evens using CTCAE V5.0 criteria associated with the
      procedure through 90 days (short-term) and 12 months (intermediate term). Efficacy will be
      evaluated by assessing atrial fibrillation recurrence (for paroxysmal AF) or AF burden (for
      persistent AF) after 90 days of blank period until 12 months post-treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 90 days adverse events by CTCA5
time frame: 90 days
description: Safety will be assessed by incidence and evaluation of any adverse events using CTCA5 V5.0 criteria that are related to the procedure
measure: 12 months adverse events by CTCA5
time frame: 12 months
description: Safety will be assessed by incidence and evaluation of any adverse events using CTCA5 V5.0 criteria that are related to the procedure
measure: Recurrence of atrial fibrillation (for paroxysmal atrial fibrillation)
time frame: 90 days to 12 months
description: Recurrence of atrial fibrillation after 90 days blanking period post-treatment
measure: Atrial fibrillation burden reduction (for persistent atrial fibrillation)
time frame: 90 days to 12 months
description: Atrial fibriilation burden reduction after 90 days blanking period post-treatment
measure: All-cause motality
time frame: 12 months
description: Motality due to any reason
measure: Quality of life improvement
time frame: 3 month, 6 month and 12 month
description: Quality of life after the procedure evaluated by the questionnaire
arm group label: stereotactic body radiotherapy (SBRT)
arm group type: Experimental
description: Noninvasive SBRT will be delivered in a single fraction to electrical isolate the pulmonary veins under CT-guidance.
intervention type: Radiation
intervention name: Stereotactic Radiotherapy
description: Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation
arm group label: stereotactic body radiotherapy (SBRT)
criteria: 
gender: All
minimum age: 55 Years
maximum age: 89 Years
healthy volunteers: No
last name: Yi-Gang Li
role: Principal Investigator
affiliation: Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
last name: Yi-Gang Li
phone: 86-21-25077260
email: liyigang@xinhuamed.com.cn
last name: Mu Chen
email: chenmu@xinhuamed.com.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Atrial Fibrillation