<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/NCT03811795</url>
  </required_header>
  <id_info>
    <org_study_id>ABCRYO1786</org_study_id>
    <nct_id>NCT03811795</nct_id>
  </id_info>
  <brief_title>Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib</brief_title>
  <official_title>Cryoballoon vs. Rhythmia Guided Ablation for Recurrent Atrial Fibrillation Following Initial Cryoballoon Pulmonary Vein Isolation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Valley Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Valley Health System</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency&#xD;
      ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform&#xD;
      repeat ablation for recurrent atrial fibrillation after previously having undergone&#xD;
      cryoballoon ablation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a randomized, prospective multicenter pilot study to assess the utility and&#xD;
      efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in&#xD;
      subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon&#xD;
      PVI.&#xD;
&#xD;
      After obtaining informed consent to participate in the study, subjects will undergo baseline&#xD;
      data bcollection. Subjects will then be randomized to undergo repeat PVI with either&#xD;
      cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved&#xD;
      ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and&#xD;
      IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the&#xD;
      cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in&#xD;
      accordance with standard clinical indications and practice, regardless of participation in&#xD;
      the study.&#xD;
&#xD;
      The participants in the study will undergo a total of two follow-up visits after ablation&#xD;
      (approximately 3 and 6 months) with a 12-lead electrocardiogram (ECG) at each visit. An&#xD;
      assessment of rhythm will be performed with daily transmissions as well as subject-activated&#xD;
      event recordings for symptoms with the Kardia Mobile (AliveCor, Mountain View, CA) smartphone&#xD;
      based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor&#xD;
      coupled with a smartphone app that is able to record a single-lead ECG and securely transmit&#xD;
      the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant)&#xD;
      remote monitoring service for clinicians. The transmissions will not be directly available to&#xD;
      the treating electrophysiologists at each site.&#xD;
&#xD;
      At the 6 month visit, 2-weeks of continuous monitoring with a Zio XT event monitor (iRhythm,&#xD;
      San Francisco, CA) will be performed according to standard clinical practice to evaluate for&#xD;
      subclinical episodes of AF.&#xD;
&#xD;
      The goal of the pilot study is to enroll 50 subjects with 1:1 randomization across 3 sites in&#xD;
      the Unites States and each subject will be followed for 6 months following ablation to&#xD;
      evaluate for recurrence of AF. The estimated time to complete enrollment will be 3-4 months&#xD;
      assuming enrollment of at each visit 4-5 subject per month at each site.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 27, 2018</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2022</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>
    <intervention_model_description>The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI.&#xD;
After obtaining informed consent to participate in the study, subjects will undergo baseline data collection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib</measure>
    <time_frame>Six months</time_frame>
    <description>The freedom from atrial fibrillation at 6 months is the primary endpoint. The presence or absence of atrial fibrillation will be assessed during the study period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Arm 1-Repeat Cryoballoon Ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects will be randomized to repeat cryoballoon ablation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2-Radiofrequency Ablation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will have radiofrequency ablation guided by high-fidelity mapping (Rhythmia) following an initial cryoballoon ablation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ECG monitoring with a Kardia Mobile monitor</intervention_name>
    <description>The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians.</description>
    <arm_group_label>Arm 1-Repeat Cryoballoon Ablation</arm_group_label>
    <arm_group_label>Arm 2-Radiofrequency Ablation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals with paroxysmal or persistent AF undergoing repeat AF ablation as per&#xD;
             recent HRS guidelines and standard practice;&#xD;
&#xD;
          -  Individuals in whom the initial ablation approach was cryoballoon PVI at the enrolling&#xD;
             institution more than 3 month or more prior to the anticipated repeat ablation;&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with recurrent AF who previously underwent RF-based PVI;&#xD;
&#xD;
          -  Individuals with known contraindications to ablation including permanent atrial&#xD;
             fibrillation or intolerance of anticoagulation;&#xD;
&#xD;
          -  Individuals unable or not willing to complete follow-up visits and examination for the&#xD;
             duration of the study;&#xD;
&#xD;
          -  Individuals without access to smartphone or tablet compatible with the monitoring&#xD;
             system;&#xD;
&#xD;
          -  Prior valve surgery or surgical AF ablation;&#xD;
&#xD;
          -  Individuals with mental or physical limitations precluding informed consent;&#xD;
&#xD;
          -  Individuals currently enrolled in another investigational study or registry;&#xD;
&#xD;
          -  Women of childbearing potential who are, or plan to become, pregnant during the time&#xD;
             of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Advay Bhatt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Valley Hosptial</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kathleen Sayles, BSN</last_name>
    <phone>201-389-0204</phone>
    <email>ksayles@valleyhealth.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Iowa Heart Center</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Burg, BSN</last_name>
      <phone>515-633-3845</phone>
      <email>scburg@iowaheart.com</email>
    </contact>
    <investigator>
      <last_name>Troy Hounshell, DO</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Valley Hospital</name>
      <address>
        <city>Paramus</city>
        <state>New Jersey</state>
        <zip>07652</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kathleen Sayles, BSN</last_name>
      <phone>201-389-0204</phone>
      <email>ksayles@valleyhealth.com</email>
    </contact>
    <investigator>
      <last_name>Advay Bhatt, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Peace Health</name>
      <address>
        <city>Springfield</city>
        <state>Oregon</state>
        <zip>97477</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherry Beaver, MS</last_name>
      <phone>541-222-1925</phone>
      <email>sbeaver@peacehealth.org</email>
    </contact>
    <investigator>
      <last_name>Sree Karanam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2021</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/NCT03811795
org study id: ABCRYO1786
nct id: NCT03811795
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The purpose of this research is to evaluate whether cryoballoon ablation vs. radiofrequency
      ablation guided by high-fidelity mapping (Rhythmia) is the best treatment strategy to perform
      repeat ablation for recurrent atrial fibrillation after previously having undergone
      cryoballoon ablation.
The study is a randomized, prospective multicenter pilot study to assess the utility and
      efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in
      subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon
      PVI.

      After obtaining informed consent to participate in the study, subjects will undergo baseline
      data bcollection. Subjects will then be randomized to undergo repeat PVI with either
      cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved
      ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and
      IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the
      cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in
      accordance with standard clinical indications and practice, regardless of participation in
      the study.

      The participants in the study will undergo a total of two follow-up visits after ablation
      (approximately 3 and 6 months) with a 12-lead electrocardiogram (ECG) at each visit. An
      assessment of rhythm will be performed with daily transmissions as well as subject-activated
      event recordings for symptoms with the Kardia Mobile (AliveCor, Mountain View, CA) smartphone
      based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor
      coupled with a smartphone app that is able to record a single-lead ECG and securely transmit
      the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant)
      remote monitoring service for clinicians. The transmissions will not be directly available to
      the treating electrophysiologists at each site.

      At the 6 month visit, 2-weeks of continuous monitoring with a Zio XT event monitor (iRhythm,
      San Francisco, CA) will be performed according to standard clinical practice to evaluate for
      subclinical episodes of AF.

      The goal of the pilot study is to enroll 50 subjects with 1:1 randomization across 3 sites in
      the Unites States and each subject will be followed for 6 months following ablation to
      evaluate for recurrence of AF. The estimated time to complete enrollment will be 3-4 months
      assuming enrollment of at each visit 4-5 subject per month at each site.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a randomized, prospective multicenter pilot study to assess the utility and efficacy of high-density mapping with the Rhythmia mapping system to guide PV re-isolation in subjects with recurrent AF after an initial cryoballoon PVI compared to repeat cryoballoon PVI.
After obtaining informed consent to participate in the study, subjects will undergo baseline data collection. Subjects will then be randomized to undergo repeat PVI with either cryoballoon ablation or repeat PVI with an IntellaNav Open-Irrigated or other approved ablation catheters for atrial fibrillation under guidance of the Rhythmia mapping system and IntellaMap Orion mapping catheter. The performance of repeat AF ablation, use either the cryoballoon or Rhythmia mapping system, mapping catheter, and ablation catheters are in accordance with standard clinical indications and practice, regardless of participation in the study.
primary purpose: Treatment
masking: Single (Participant)
measure: PrimaryCryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
time frame: Six months
description: The freedom from atrial fibrillation at 6 months is the primary endpoint. The presence or absence of atrial fibrillation will be assessed during the study period.
arm group label: Arm 1-Repeat Cryoballoon Ablation
arm group type: Other
description: Subjects will be randomized to repeat cryoballoon ablation.
arm group label: Arm 2-Radiofrequency Ablation
arm group type: Other
description: Participants will have radiofrequency ablation guided by high-fidelity mapping (Rhythmia) following an initial cryoballoon ablation.
intervention type: Other
intervention name: ECG monitoring with a Kardia Mobile monitor
description: The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians.
arm group label: Arm 1-Repeat Cryoballoon Ablation
arm group label: Arm 2-Radiofrequency Ablation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Advay Bhatt, MD
role: Principal Investigator
affiliation: The Valley Hosptial
last name: Kathleen Sayles, BSN
phone: 201-389-0204
email: ksayles@valleyhealth.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Atrial Fibrillation