<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/NCT01679132</url>
  </required_header>
  <id_info>
    <org_study_id>360039</org_study_id>
    <nct_id>NCT01679132</nct_id>
  </id_info>
  <brief_title>BAROSTIM NEO Hypertension Pivotal Trial</brief_title>
  <official_title>BAROSTIM NEO Hypertension Pivotal Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CVRx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CVRx, Inc.</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_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety&#xD;
      and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM&#xD;
      Hypertension Pivotal Trial (G120137).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing&#xD;
      the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.&#xD;
&#xD;
      All subjects are now in long term follow-up and are required to have at least one annual&#xD;
      visit.&#xD;
&#xD;
      Parameters assessed during visits are:&#xD;
&#xD;
        -  Office Cuff Blood Pressure&#xD;
&#xD;
        -  Physical Assessment&#xD;
&#xD;
        -  Subject Medications&#xD;
&#xD;
        -  Serious adverse events&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Company resources only allows adequate oversight for one pivotal trial at a time&#xD;
  </why_stopped>
  <start_date>April 12, 2013</start_date>
  <completion_date type="Anticipated">March 2026</completion_date>
  <primary_completion_date type="Anticipated">March 2026</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>To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.</measure>
    <time_frame>For the duration of the study, up to ten years.</time_frame>
    <description>Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Uncontrolled Hypertension</condition>
  <arm_group>
    <arm_group_label>BAROSTIM NEO System</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects implanted with the BAROSTIM NEO System.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BAROSTIM NEO System and Medical Management</intervention_name>
    <description>Experimental: Device and Medical Management&#xD;
Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.</description>
    <arm_group_label>BAROSTIM NEO System</arm_group_label>
    <other_name>Neo System</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Actively participating in the Barostim Hypertension Pivotal Trial and currently&#xD;
             implanted with the BAROSTIM NEO device with the device turned ON.&#xD;
&#xD;
          -  Have signed a revised approved informed consent form for continued participation in&#xD;
             this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treating physician decision that the subject should not continue with therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>George Bakris, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The University of Chicago Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>John Bisognano, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fred Weaver, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Keck School of Medicine of the University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Abraham, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Heart Rhythm Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute of the South</name>
      <address>
        <city>Houma</city>
        <state>Louisiana</state>
        <zip>70360</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac and Vascular Research Center of Northern Michigan</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan CardioVascular Institute</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center of Southern Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Wausau Hospital</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 18, 2023</last_update_submitted>
  <last_update_submitted_qc>April 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 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>Hypertension</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/NCT01679132
org study id: 360039
nct id: NCT01679132
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety
      and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM
      Hypertension Pivotal Trial (G120137).
The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing
      the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

      All subjects are now in long term follow-up and are required to have at least one annual
      visit.

      Parameters assessed during visits are:

        -  Office Cuff Blood Pressure

        -  Physical Assessment

        -  Subject Medications

        -  Serious adverse events
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
time frame: For the duration of the study, up to ten years.
description: Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
arm group label: BAROSTIM NEO System
arm group type: Experimental
description: Subjects implanted with the BAROSTIM NEO System.
intervention type: Device
intervention name: BAROSTIM NEO System and Medical Management
description: Experimental: Device and Medical Management
Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.
arm group label: BAROSTIM NEO System
other name: Neo System
criteria: 
gender: All
minimum age: 21 Years
maximum age: 80 Years
healthy volunteers: No
last name: George Bakris, MD
role: Study Chair
affiliation: The University of Chicago Medicine
last name: John Bisognano, MD
role: Study Chair
affiliation: University of Rochester
last name: Fred Weaver, MD
role: Study Chair
affiliation: Keck School of Medicine of the University of Southern California
last name: William Abraham, MD
role: Study Chair
affiliation: Ohio State University
facility: 
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country: United States
responsible party type: Sponsor
mesh term: Hypertension