xml: <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/NCT05988411</url>
    </required_header>
    <id_info>
      <org_study_id>BRANY 23-02-344</org_study_id>
      <nct_id>NCT05988411</nct_id>
    </id_info>
    <brief_title>ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients</brief_title>
    <official_title>Ultrasound-Based Renal Sympathetic Denervation as Adjunctive Upstream Therapy During Atrial Fibrillation - Redo Ablation Procedures: A Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Vivek Reddy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Icahn School of Medicine at Mount Sinai</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control)&#xD;
        clinical trial. The purpose of the study is to determine the role of adjunctive renal&#xD;
        sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients&#xD;
        with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF.&#xD;
        Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal&#xD;
        sympathetic denervation (Intervention).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, controlled, single-blind, randomized trial. The pilot study will be&#xD;
        conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and&#xD;
        running (expected to take 6 months), accrual is expected to take an additional 9 months, and&#xD;
        all patients will be followed for 12 months post randomization. Patients, the Clinical Events&#xD;
        Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded&#xD;
        at the 12-month visit.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</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>Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>single-blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Freedom from atrial arrhythmias with no AADs</measure>
      <time_frame>after 90 days</time_frame>
      <description>Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Freedom from atrial arrhythmias (AT/AF/AFL) with AADs</measure>
      <time_frame>at 12 months</time_frame>
      <description>Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Procedure-related adverse events</measure>
      <time_frame>at 12 months</time_frame>
      <description>Number of procedure-related adverse events</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)</measure>
      <time_frame>at 12 months</time_frame>
      <description>Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>at 12 months</time_frame>
      <description>Blood pressure - Systolic and Diastolic</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of AF episodes</measure>
      <time_frame>at 12 months</time_frame>
      <description>AF burden assessed by the amount of AF episodes detected during Event Monitoring</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <condition>Persistent Atrial Fibrillation</condition>
    <arm_group>
      <arm_group_label>Catheter ablation + renal denervation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Catheter ablation + renal denervation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Catheter ablation only</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Catheter ablation</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Renal Denervation</intervention_name>
      <description>Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy</description>
      <arm_group_label>Catheter ablation + renal denervation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Catheter Ablation</intervention_name>
      <description>Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.</description>
      <arm_group_label>Catheter ablation + renal denervation</arm_group_label>
      <arm_group_label>Catheter ablation only</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18;&#xD;
  &#xD;
            -  Planned for a redo AF ablation procedure (paroxysmal or persistent); (prior to&#xD;
               randomization, a technically successful AF ablation procedure, defined as successful&#xD;
               pulmonary vein isolation, if needed, as well as bidirectional block of any attempted&#xD;
               anatomic lesion sets such as cavotricuspid isthmus line, roofline, mitral line and&#xD;
               superior vena cava isolation, must have been completed). Note: the clinical&#xD;
               recurrences must primarily be atrial fibrillation, and not atrial flutter/tachycardia&#xD;
               (that is, a prospective patient may have a AFL/AT recurrences, but AF must be the&#xD;
               dominant recurrent rhythm.)&#xD;
  &#xD;
            -  History of hypertension and either:&#xD;
  &#xD;
                 -  Documented history of SBP≥160 or DBP≥100, or;&#xD;
  &#xD;
                 -  Receiving ≥1 antihypertensive medication;&#xD;
  &#xD;
            -  Willingness to adhere to study restrictions and comply with all post-procedural&#xD;
               follow-up requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Long-standing persistent AF (&gt;12 months); &gt;3 prior atrial fibrillation ablations&#xD;
               (lifetime); AF ablation within 3 months of enrollment; extensive scar in left atrium.&#xD;
  &#xD;
            -  Individual with valvular AF or AF due to a reversible cause&#xD;
  &#xD;
            -  Prior treatment with other devices for hypertension including but not limited to ROX&#xD;
               Coupler, Mobius stent, and/or the CVRx barostimulator device.&#xD;
  &#xD;
            -  NYHA class IV congestive heart failure;&#xD;
  &#xD;
            -  Individual has renal artery anatomy that is ineligible for treatment (as determined by&#xD;
               renal angiography);&#xD;
  &#xD;
                 -  Main renal artery diameter &lt;3mm or &gt;8.0 mm&#xD;
  &#xD;
                 -  Main renal treatable artery length &lt; 20 mm (length may include proximal branches)&#xD;
  &#xD;
                 -  Presence of renal artery stenosis of any origin ≥30%&#xD;
  &#xD;
                 -  Calcification in renal arteries&#xD;
  &#xD;
                 -  Prior renal denervation procedure&#xD;
  &#xD;
                 -  Presence of abnormal kidney tumors&#xD;
  &#xD;
                 -  Renal artery aneurysm&#xD;
  &#xD;
                 -  Pre-existing renal stent or history of renal artery angioplasty&#xD;
  &#xD;
                 -  Pre-existing aortic stent or history of aortic aneurysm&#xD;
  &#xD;
                 -  Fibromuscular disease of the renal arteries&#xD;
  &#xD;
                 -  Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter&#xD;
  &#xD;
            -  Individual has an estimated glomerular filtration rate (eGFR) of less than&#xD;
               40mL/min/1.73m2, using the MDRD calculation;&#xD;
  &#xD;
            -  Inability to undergo AF catheter ablation (e.g., presence of a left atrial thrombus,&#xD;
               contraindication to all anticoagulation)&#xD;
  &#xD;
            -  Individual with known allergy to contrast medium not amendable to treatment.&#xD;
  &#xD;
            -  Life expectancy &lt;1 year for any medical condition&#xD;
  &#xD;
            -  Individual has experienced a myocardial infarction, unstable angina, cerebrovascular&#xD;
               accident, or heart failure admission within 3 months of the baseline visit.&#xD;
  &#xD;
            -  Documented history of chronic active inflammatory bowel disorders such as Crohn's&#xD;
               disease or ulcerative colitis.&#xD;
  &#xD;
            -  Female participants who are pregnant or nursing.&#xD;
  &#xD;
            -  Individual has known secondary hypertension.&#xD;
  &#xD;
            -  Individual has a single functioning kidney (either congenitally or iatrogenically).&#xD;
  &#xD;
            -  Individual has a known, unresolved history of drug use or alcohol dependency, lacks&#xD;
               the ability to comprehend or follow instructions, or would be unlikely or unable to&#xD;
               comply with study follow-up requirements.&#xD;
  &#xD;
            -  Patients concurrently enrolled in any other investigational drug or device trial that&#xD;
               would interfere with the conduction of this protocol.&#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>Vivek Reddy, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>MOUNT SINAI HOSPITAL</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jeff Lam, MS</last_name>
      <phone>(212) 824-8929</phone>
      <email>jeff.lam@mountsinai.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Betsy Ellsworth, MSN ANP</last_name>
      <phone>(212) 824-8902</phone>
      <email>betsy.ellsworth@mountsinai.org</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mount Sinai Hospital</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10029</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Jeff Lam, MS</last_name>
        <phone>212-824-8929</phone>
        <email>jeff.lam@mountsinai.org</email>
      </contact>
      <contact_backup>
        <last_name>Betsy Ellsworth, MSN ANP</last_name>
        <phone>(212) 824-8902</phone>
        <email>betsy.ellsworth@mountsinai.org</email>
      </contact_backup>
      <investigator>
        <last_name>Abhishek Maan</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 4, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
      <investigator_full_name>Vivek Reddy</investigator_full_name>
      <investigator_title>Professor of Medicine , Director, Cardiac Electrophysiology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Atrial Fibrillation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05988411
  org study id: BRANY 23-02-344
  nct id: NCT05988411
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This is a Prospective, controlled, single-blind, randomized (2:1, Intervention:Control)
        clinical trial. The purpose of the study is to determine the role of adjunctive renal
        sympathetic denervation in the prevention of Atrial Fibrillation (AF) recurrence in patients
        with hypertension scheduled for a redo AF ablation procedure for paroxysmal or persistent AF.
        Patients will be randomized to either i) AF ablation (Control) or ii) AF ablation + renal
        sympathetic denervation (Intervention).
  This is a prospective, controlled, single-blind, randomized trial. The pilot study will be
        conducted in up to 20 clinical sites in the United States. Once the clinical sites are up and
        running (expected to take 6 months), accrual is expected to take an additional 9 months, and
        all patients will be followed for 12 months post randomization. Patients, the Clinical Events
        Committee and the ECG core lab will be blinded during the trial. Patients will be unblinded
        at the 12-month visit.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Prospective, controlled, single-blind, randomized (2:1, Intervention:Control) clinical trial.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: single-blind
  measure: Freedom from atrial arrhythmias with no AADs
  time frame: after 90 days
  description: Freedom from atrial arrhythmias (AT/AF/AFL) recurrence ≥ 30 seconds off all antiarrhythmic drug uses (AADs) (after the 90-day blanking period).
  measure: Freedom from atrial arrhythmias (AT/AF/AFL) with AADs
  time frame: at 12 months
  description: Freedom from AT/AF/AFL recurrence ≥ 30 seconds at 12 months (not including a 3-month blanking period) despite taking AADs
  measure: Procedure-related adverse events
  time frame: at 12 months
  description: Number of procedure-related adverse events
  measure: Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT)
  time frame: at 12 months
  description: Atrial Fibrillation Effect on Qualify of Life Questionnaire (AFEQT). Each item scored from 1-7, with total scale from 20-140, Lower score indicates better health outcomes.
  measure: Blood pressure
  time frame: at 12 months
  description: Blood pressure - Systolic and Diastolic
  measure: Number of AF episodes
  time frame: at 12 months
  description: AF burden assessed by the amount of AF episodes detected during Event Monitoring
  arm group label: Catheter ablation + renal denervation
  arm group type: Experimental
  description: Catheter ablation + renal denervation
  arm group label: Catheter ablation only
  arm group type: Active Comparator
  description: Catheter ablation
  intervention type: Device
  intervention name: Renal Denervation
  description: Renal denervation using the Paradise renal denervation system - a dedicated Renal Denervation (RDN) catheter that delivers a circumferential ring of ablative ultrasound energy
  arm group label: Catheter ablation + renal denervation
  intervention type: Device
  intervention name: Catheter Ablation
  description: Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation.
  arm group label: Catheter ablation + renal denervation
  arm group label: Catheter ablation only
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Vivek Reddy, MD
  role: Principal Investigator
  affiliation: MOUNT SINAI HOSPITAL
  last name: Jeff Lam, MS
  phone: (212) 824-8929
  email: jeff.lam@mountsinai.org
  last name: Betsy Ellsworth, MSN ANP
  phone: (212) 824-8902
  email: betsy.ellsworth@mountsinai.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Icahn School of Medicine at Mount Sinai
  investigator full name: Vivek Reddy
  investigator title: Professor of Medicine , Director, Cardiac Electrophysiology
  mesh term: Atrial Fibrillation
  sharing ipd: No