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/NCT05970120</url>
    </required_header>
    <id_info>
      <org_study_id>BWI202104</org_study_id>
      <secondary_id>BWI202104</secondary_id>
      <nct_id>NCT05970120</nct_id>
    </id_info>
    <brief_title>A Study of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter</brief_title>
    <official_title>Clinical Evaluation of Intracardiac Ultrasound With the NUVISION NAV Ultrasound Catheter</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Biosense Webster, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Biosense Webster, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess the performance and safety of using the&#xD;
        investigational catheter.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 5, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 24, 2023</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>Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter</measure>
      <time_frame>Up to 5 months</time_frame>
      <description>Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Participants with Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter</measure>
      <time_frame>Up to 7 days of index procedure</time_frame>
      <description>Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures</measure>
      <time_frame>Up to 5 months</time_frame>
      <description>Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure</measure>
      <time_frame>Up to 7 days of index procedure</time_frame>
      <description>Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter</measure>
      <time_frame>Up to 7 days of index procedure</time_frame>
      <description>Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Scar-related Atrial Tachycardia</condition>
    <condition>Persistent Atrial Fibrillation</condition>
    <condition>Paroxysmal Atrial Fibrillation</condition>
    <condition>Ventricular Tachycardia</condition>
    <condition>Premature Ventricular Complex</condition>
    <arm_group>
      <arm_group_label>NUVISION NAV Ultrasound Catheter</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation [PsAF], paroxysmal atrial fibrillation [PVF], ventricular tachycardia [VT], and premature ventricular complex [PVC]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NUVISION NAV Ultrasound Catheter</intervention_name>
      <description>Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.</description>
      <arm_group_label>NUVISION NAV Ultrasound Catheter</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed with and candidate for clinically-indicated cardiac ablation procedure for&#xD;
               the management of ventricular tachycardia, premature ventricular complex, scar-related&#xD;
               atrial tachycardia or atrial fibrillation (participants having undergone a previous&#xD;
               ablation procedure may be included)&#xD;
  &#xD;
            -  Signed participants Informed Consent Form (ICF)&#xD;
  &#xD;
            -  Able and willing to comply with all pre-, post-, and follow-up testing and&#xD;
               requirements&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Structural heart defect which can only be repaired by cardiac surgery&#xD;
  &#xD;
            -  Pericarditis within 6 months&#xD;
  &#xD;
            -  Left ventricular ejection fraction (LVEF) less than or equal to (&lt;=) 25 percent (%)&#xD;
               for ventricular tachycardia (VT) participants&#xD;
  &#xD;
            -  LVEF &lt;= 40% for participants with atrial arrhythmia&#xD;
  &#xD;
            -  History of chronic gastro-intestinal medical problems involving the esophagus, stomach&#xD;
               and/or untreated acid reflux&#xD;
  &#xD;
            -  History of abnormal bleeding and/or clotting disorder&#xD;
  &#xD;
            -  Clinically significant infection or sepsis&#xD;
  &#xD;
            -  History of stroke or transient ischemic attack (TIA) within the past 6 months of&#xD;
               enrollment&#xD;
  &#xD;
            -  Uncontrolled heart failure or New York Heart Association (NYHA) function class IV&#xD;
  &#xD;
            -  Implanted with a pacemaker or intracardiac cardiac defibrillator within the past 6&#xD;
               weeks (42 days)&#xD;
  &#xD;
            -  Implanted with a mechanical valve&#xD;
  &#xD;
            -  Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other&#xD;
               abnormality that precludes catheter introduction or manipulation&#xD;
  &#xD;
            -  Any of the following within 6 months of enrollment: major surgery except for the index&#xD;
               procedure, myocardial infarction, unstable angina, percutaneous coronary intervention&#xD;
  &#xD;
            -  Participants with any other significant uncontrolled or unstable medical condition&#xD;
               (such as uncontrolled bradyarrhythmia's, ventricular arrhythmias, hyperthyroidism, or&#xD;
               significant coagulation disorder)&#xD;
  &#xD;
            -  Significant congenital anomaly or medical problem that in the opinion of the&#xD;
               investigator would preclude enrollment in this study&#xD;
  &#xD;
            -  Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating,&#xD;
               or who are of childbearing age and plan on becoming pregnant during the course of the&#xD;
               clinical investigation&#xD;
  &#xD;
            -  Categorized as vulnerable population and requires special treatment with respect to&#xD;
               safeguards of well-being&#xD;
  &#xD;
            -  Concurrent enrollment in an investigational study evaluating another device or drug&#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>Biosense Webster, Inc Clinical Trial</last_name>
      <role>Study Director</role>
      <affiliation>Biosense Webster, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Contact</last_name>
      <phone>+32 479 97 05 05</phone>
      <email>nmacours1@its.jnj.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>KBC Split</name>
        <address>
          <city>Split</city>
          <zip>21000</zip>
          <country>Croatia</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Sourasky (Ichilov) Medical Center</name>
        <address>
          <city>Tel Aviv-Yafo</city>
          <zip>6423906</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Yitzhak Shamir Medical Center</name>
        <address>
          <city>Zerifin</city>
          <zip>7033001</zip>
          <country>Israel</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Centro Cardiologico Monzino</name>
        <address>
          <city>Milano</city>
          <zip>20138</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>Croatia</country>
      <country>Israel</country>
      <country>Italy</country>
    </location_countries>
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    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</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>
      <mesh_term>Tachycardia</mesh_term>
      <mesh_term>Tachycardia, Ventricular</mesh_term>
      <mesh_term>Ventricular Premature Complexes</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Johnson &amp; Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu</ipd_description>
      <ipd_url>http://yoda.yale.edu</ipd_url>
    </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/NCT05970120
  org study id: BWI202104
  secondary id: BWI202104
  nct id: NCT05970120
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The purpose of this study is to assess the performance and safety of using the
        investigational catheter.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Number of Participants with Completion of Imaging with the NUVISION NAV Ultrasound Catheter Without Resort to Non-study Mapping Catheter
  time frame: Up to 5 months
  description: Number of participants who have successfully completed the procedure (imaging with the NUVISION NAV ultrasound catheter) without resort to a non-study ultrasound device will be reported.
  measure: Number of Participants with Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
  time frame: Up to 7 days of index procedure
  description: Number of participants with SAEs within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
  measure: Physician Assessment of Deployment, Maneuverability, Navigational Features and Imaging Quality Acquired with the NUVISION NAV Ultrasound Catheter During the Study Procedures
  time frame: Up to 5 months
  description: Physician assessment on deployment, maneuverability, navigational features, and imaging quality acquired with the NUVISION NAV ultrasound catheter will be reported. A post-procedure survey will be administered. Each question/sub-question will be answered by the physician using a Likert scale of 1 to 7 (1=poor and 7=excellent) and will be summarized.
  measure: Number of Participants with Other SAEs (Excluding NUVISION NAV Ultrasound Catheter Related SAE) Within 7 Days of Index Procedure
  time frame: Up to 7 days of index procedure
  description: Number of Participants with other SAEs (excluding NUVISION NAV ultrasound catheter related SAE) within 7 days of index procedure will be reported. A serious adverse device effect is an adverse device effect that has resulted in any of the consequences characteristic of an SAE. An SAE is any event that meets one or more of the following criteria: a) leads to death; b) leads to a serious deterioration in the health of a participant that resulted in: i) life-threatening illness or injury; ii) an injury or permanent impairment of a body structure or a body function; iii) in-patient hospitalization or prolongation of an existing hospitalization; iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or a body function; v) chronic disease; d) leads to fetal distress, fetal death or a congenital abnormality or birth defect.
  measure: Number of Participants with Non-serious Adverse Events Within 7 Days of Index Procedure Related to the NUVISION NAV Ultrasound Catheter
  time frame: Up to 7 days of index procedure
  description: Number of participants with non-serious adverse events within 7 days of index procedure related to the NUVISION NAV ultrasound catheter will be reported. An adverse event is any untoward medical occurrence in a participant whether or not related to the investigational device.
  arm group label: NUVISION NAV Ultrasound Catheter
  arm group type: Experimental
  description: Participants with five different subgroups (scar-related atrial tachycardia, persistent atrial fibrillation [PsAF], paroxysmal atrial fibrillation [PVF], ventricular tachycardia [VT], and premature ventricular complex [PVC]) will be treated using NUVISION NAV ultrasound catheter per investigator's standard of care and followed until 7 days post-procedure.
  intervention type: Device
  intervention name: NUVISION NAV Ultrasound Catheter
  description: Participants will be scheduled to have a clinically-indicated ablation procedure using NUVISION NAV ultrasound catheter for management of atrial procedure.
  arm group label: NUVISION NAV Ultrasound Catheter
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Biosense Webster, Inc Clinical Trial
  role: Study Director
  affiliation: Biosense Webster, Inc.
  last name: Study Contact
  phone: +32 479 97 05 05
  email: nmacours1@its.jnj.com
  facility: 
  status: Recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  facility: 
  status: Not yet recruiting
  country: Croatia
  country: Israel
  country: Italy
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  responsible party type: Sponsor
  mesh term: Atrial Fibrillation
  mesh term: Tachycardia
  mesh term: Tachycardia, Ventricular
  mesh term: Ventricular Premature Complexes
  sharing ipd: Yes
  ipd description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
  ipd url: http://yoda.yale.edu