<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/NCT01720160</url>
  </required_header>
  <id_info>
    <org_study_id>360032-001</org_study_id>
    <nct_id>NCT01720160</nct_id>
  </id_info>
  <brief_title>BAROSTIM® Hope for Heart Failure Study</brief_title>
  <acronym>HOPE4HF</acronym>
  <official_title>Barostim HOPE4HF Study</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 is to assess the long-term safety and efficacy of&#xD;
      the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial&#xD;
      (NCT01720160).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System&#xD;
      in heart failure subjects with left ventricular ejection fraction equal to or less than 35&#xD;
      percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the&#xD;
      device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31,&#xD;
      2014. Subjects are in long-term follow-up and are required to have at least one annual visit.&#xD;
      During the visit, there will be a physical assessment, a review of medications and serious&#xD;
      adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">March 2021</completion_date>
  <primary_completion_date type="Actual">May 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Heart failure metric improvements from baseline</measure>
    <time_frame>12 months</time_frame>
    <description>To describe changes in measures compared to baseline.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>System and procedure related adverse events</measure>
    <time_frame>6 months</time_frame>
    <description>To demonstrate the safety of the Neo system in a heart failure population.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Management</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BAROSTIM NEO® System</intervention_name>
    <description>Implant procedure</description>
    <arm_group_label>Device</arm_group_label>
    <other_name>Neo® System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care medical managment therapy for heart failure</intervention_name>
    <description>Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.</description>
    <arm_group_label>Device</arm_group_label>
    <arm_group_label>Medical Management</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Actively participating in the BAROSTIM HOPE4HF Study and currently implanted with the&#xD;
             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>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Zile, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William Abraham, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fred Weaver, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Faiez Zannad, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inserm Centre d'Investigation, CHU de Nancy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>JoAnn Lindenfield, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt Heart and Vascular Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Cardiovascular Associates</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Heart Rhythm Research Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>53226</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>ACRC - Cardiology</name>
      <address>
        <city>Atlantis</city>
        <state>Florida</state>
        <zip>33462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</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>Piedmont Heart Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advocate Medical Group</name>
      <address>
        <city>Naperville</city>
        <state>Illinois</state>
        <zip>60540</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>St Elizabeth's Medical Center</name>
      <address>
        <city>Brighton</city>
        <state>Massachusetts</state>
        <zip>02135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mid-Michigan Medical Center Midland</name>
      <address>
        <city>Midland</city>
        <state>Michigan</state>
        <zip>48670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac &amp; 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>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</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>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Cardiovascular Research Group</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drexel University College of Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19102</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>Lonestar Heart Center</name>
      <address>
        <city>Amarillo</city>
        <state>Texas</state>
        <zip>79106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wheaton Franciscan Healthcare</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Heart &amp; Vascular Institute</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>55401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.</citation>
    <PMID>25982108</PMID>
  </results_reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>October 29, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <disposition_first_submitted>August 30, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>August 30, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">September 1, 2016</disposition_first_posted>
  <last_update_submitted>May 8, 2019</last_update_submitted>
  <last_update_submitted_qc>May 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systolic Heart Failure</keyword>
  <keyword>Congestive Heart Failure</keyword>
  <keyword>Reduced left ventricular ejection fraction</keyword>
  <keyword>HFrEF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01720160
org study id: 360032-001
nct id: NCT01720160
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 is to assess the long-term safety and efficacy of
      the BAROSTIM NEO System in subjects currently participating in the BAROSTIM® HOPE4HF Trial
      (NCT01720160).
A prospective, randomized study describing the safety and efficacy of the BAROSTIM NEO System
      in heart failure subjects with left ventricular ejection fraction equal to or less than 35
      percent. Seventy two subjects were randomized; 32 to the medical management arm and 40 to the
      device arm (38 implanted, 2 withdrawn). The study closed to new enrollments on January 31,
      2014. Subjects are in long-term follow-up and are required to have at least one annual visit.
      During the visit, there will be a physical assessment, a review of medications and serious
      adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Heart failure metric improvements from baseline
time frame: 12 months
description: To describe changes in measures compared to baseline.
measure: System and procedure related adverse events
time frame: 6 months
description: To demonstrate the safety of the Neo system in a heart failure population.
arm group label: Device
arm group type: Experimental
description: 1) BAROSTIM NEO System and 2) standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
arm group label: Medical Management
arm group type: Active Comparator
description: Standard of care medical management therapy for heart failure (American Heart Association [AHA] / American College of Cardiology [ACC] guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
intervention type: Device
intervention name: BAROSTIM NEO® System
description: Implant procedure
arm group label: Device
other name: Neo® System
intervention type: Other
intervention name: Standard of care medical managment therapy for heart failure
description: Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
arm group label: Device
arm group label: Medical Management
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Zile, MD
role: Study Chair
affiliation: Medical University of South Carolina
last name: William Abraham, MD
role: Principal Investigator
affiliation: Ohio State University
last name: Fred Weaver, MD
role: Principal Investigator
affiliation: University of Southern California
last name: Faiez Zannad, MD
role: Principal Investigator
affiliation: Inserm Centre d'Investigation, CHU de Nancy
last name: JoAnn Lindenfield, MD
role: Principal Investigator
affiliation: Vanderbilt Heart and Vascular Institute
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country: United States
citation: Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
PMID: 25982108
responsible party type: Sponsor
mesh term: Heart Failure