<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/NCT04502316</url>
  </required_header>
  <id_info>
    <org_study_id>360059-001</org_study_id>
    <nct_id>NCT04502316</nct_id>
  </id_info>
  <brief_title>Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)</brief_title>
  <official_title>Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CVRx, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CVRx, Inc.</source>
  <oversight_info>
    <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>
      The purpose of this registry is to develop valid scientific evidence of the safety and&#xD;
      benefit of Barostim Therapy in the commercial setting in patients with heart failure with&#xD;
      reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Summary:&#xD;
&#xD;
      The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim&#xD;
      System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken&#xD;
      prior to implant, at implant, and every six months after device implant, up to the 36-month&#xD;
      visit at which time each patient will be exited from the registry.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 26, 2020</start_date>
  <completion_date type="Anticipated">June 2028</completion_date>
  <primary_completion_date type="Anticipated">June 2028</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of serious adverse events related to the system or implant procedure</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Serious adverse events related to the system or implant procedure through 36 months post-implant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of heart failure hospitalizations</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Number of heart failure hospitalizations through 36 months post-implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of heart failure hospitalizations</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Duration of heart failure hospitalizations through 36 months post-implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change NYHA Classification</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Changes in NYHA Classification through 36 months post-implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in NT-proBNP</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Changes in NT-proBNP through 36 months post-implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LVEF</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Changes in LVEF through 36 months post-implant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Six Minute Hall Walk</measure>
    <time_frame>36 months post-implant</time_frame>
    <description>Changes in Six Minute Hall Walk distance through 36 months post-implant</description>
  </secondary_outcome>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Heart Failure</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Barostim™ System</intervention_name>
    <description>Implantation of the Barostim™ System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients can be included in the registry if they were implanted with a de novo Barostim&#xD;
        System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients can be included in the registry if they were implanted with a de novo&#xD;
             Barostim System. Patients must sign an informed consent form after implantation with&#xD;
             the Barostim System in order to participate in the registry.&#xD;
&#xD;
        Indications:&#xD;
&#xD;
        The Barostim System is indicated for the improvement of symptoms of heart failure - quality&#xD;
        of life, six-minute hall walk and functional status - for patients who remain symptomatic&#xD;
        despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II&#xD;
        (who had a recent history of Class III), have a left ventricular ejection fraction ≤ 35%, a&#xD;
        NT-proBNP &lt; 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization&#xD;
        Therapy (CRT) according to AHA/ACC/ESC guidelines.&#xD;
&#xD;
        Contraindications:&#xD;
&#xD;
          -  Bilateral carotid bifurcations located above the level of the mandible&#xD;
&#xD;
          -  Baroreflex failure or autonomic neuropathy&#xD;
&#xD;
          -  Uncontrolled, symptomatic cardiac bradyarrhythmias&#xD;
&#xD;
          -  Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation&#xD;
             greater than 50%&#xD;
&#xD;
          -  Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic&#xD;
             evaluation&#xD;
&#xD;
          -  Known allergy to silicone or titanium&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Thomas Deering</last_name>
    <role>Study Chair</role>
    <affiliation>Piedmont Heart Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bradley Knight</last_name>
    <role>Study Chair</role>
    <affiliation>Northwestern Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Larry Chinitz</last_name>
    <role>Study Chair</role>
    <affiliation>NYU Heart Rhythm Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Gold</last_name>
    <role>Study Chair</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elizabeth Galle</last_name>
    <phone>763-416-2876</phone>
    <email>lgalle@cvrx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Grandview Medical Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35243</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brandy Parker</last_name>
      <phone>205-971-7495</phone>
      <email>brandy_parker@grandviewhealth.com</email>
    </contact>
    <investigator>
      <last_name>Anil Rajendra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chan Heart Rhythm Institute</name>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85206</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia Rivera</last_name>
      <phone>480-773-2220</phone>
      <email>olivia@chanheartrhythm.com</email>
    </contact>
    <investigator>
      <last_name>Rodrigo Chan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Ramos</last_name>
      <phone>323-442-7983</phone>
      <email>Melissa.Ramos@med.usc.edu</email>
    </contact>
    <investigator>
      <last_name>Michael Fong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Dr. Truong Duong a Medical Corporation</name>
      <address>
        <city>Norco</city>
        <state>California</state>
        <zip>92860</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mira Tan</last_name>
      <phone>877-773-8664</phone>
      <phone_ext>102</phone_ext>
      <email>mctan@inlandcardiacep.com</email>
    </contact>
    <investigator>
      <last_name>Truong Duong</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cabrillo Cardiology Research Group</name>
      <address>
        <city>Oxnard</city>
        <state>California</state>
        <zip>93030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Robert Pierret</last_name>
      <phone>805-983-0922</phone>
      <email>repierret@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Richard Rothschild</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The George Washington University Medical Faculty Associates</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alfateh Sidahmed</last_name>
      <phone>202-741-2353</phone>
      <email>asidahmed@mfa.gwu.edu</email>
    </contact>
    <investigator>
      <last_name>Gurusher Panjrath</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Orlando Heart and Vascular Institute</name>
      <address>
        <city>Altamonte Springs</city>
        <state>Florida</state>
        <zip>32714</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heather Boone</last_name>
      <phone>407-767-7023</phone>
      <email>hbooone@heartorlando.com</email>
    </contact>
    <investigator>
      <last_name>Nandkishore Ranadive</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Solutions Institute</name>
      <address>
        <city>Bradenton</city>
        <state>Florida</state>
        <zip>34209</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Levanti</last_name>
      <phone>941-747-8789</phone>
      <email>j.levantipa@yahoo.com</email>
    </contact>
    <investigator>
      <last_name>Gino Sedillo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiac Care Group</name>
      <address>
        <city>Cape Coral</city>
        <state>Florida</state>
        <zip>33914</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anthony Giordano</last_name>
      <phone>239-574-8463</phone>
      <email>tgiordano@flccg.com</email>
    </contact>
    <investigator>
      <last_name>Joseph Freedman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Daytona Heart Group</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nick Hernandez</last_name>
      <phone>386-265-5926</phone>
      <email>jamesnhernandez@icloud.com</email>
    </contact>
    <investigator>
      <last_name>Surya Rao</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Florida Heart Rhythm Specialists</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Carlos Guadamas</last_name>
      <phone>954-210-3225</phone>
      <email>carlos.guadamas@flahrs.com</email>
    </contact>
    <investigator>
      <last_name>David Kenigsberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Naples Heart Rhythm Specialists, PA</name>
      <address>
        <city>Naples</city>
        <state>Florida</state>
        <zip>34119</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jori Richardson</last_name>
      <phone>239-263-0849</phone>
      <email>jrichardson@naplesheartrhytm.com</email>
    </contact>
    <investigator>
      <last_name>Kenneth Plunkett</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Millie Lopez</last_name>
      <phone>407-303-1578</phone>
      <email>millie.lopez@adventhealth.com</email>
    </contact>
    <investigator>
      <last_name>Hector Lozano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Interventions</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wanda Bisono</last_name>
      <phone>407-894-4880</phone>
      <email>wbisono@orlandocvi.com</email>
    </contact>
    <investigator>
      <last_name>Pradipkumar Jamnadas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nevada Heart and Vascular Center</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89118</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alicia Bracken</last_name>
      <phone>702-333-7273</phone>
      <email>aliciab@nevadaheart.com</email>
    </contact>
    <investigator>
      <last_name>Sanjay Malhorta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>DeGregorio Cardiology</name>
      <address>
        <city>Glen Ridge</city>
        <state>New Jersey</state>
        <zip>07028</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Asad Cheema</last_name>
      <phone>973-743-1121</phone>
      <email>asadmc@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>Asad Cheema</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Valley Hospital</name>
      <address>
        <city>Ridgewood</city>
        <state>New Jersey</state>
        <zip>07450</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lauren Tedeschi</last_name>
      <phone>201-447-8453</phone>
      <email>ltedesc2@Valleyhealth.com</email>
    </contact>
    <investigator>
      <last_name>Suneet Mittal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cardio Vascular Health Associates</name>
      <address>
        <city>S. River</city>
        <state>New Jersey</state>
        <zip>08882</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shashank Udyawer</last_name>
      <phone>732-238-6440</phone>
      <email>shashank.udyawer@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Rakesh Passi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Capital Cardiology</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12211</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Spadola</last_name>
      <phone>518-292-6216</phone>
      <email>tspadola@capitalcardiology.com</email>
    </contact>
    <investigator>
      <last_name>Rizwan Alimohammad</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marian David, M.D., P.C</name>
      <address>
        <city>Kew Gardens</city>
        <state>New York</state>
        <zip>11415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marian David</last_name>
      <phone>718-261-0444</phone>
      <email>mark@mdavid.com</email>
    </contact>
    <investigator>
      <last_name>Marian David</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carient Heart &amp; Vascular</name>
      <address>
        <city>Manassas</city>
        <state>Virginia</state>
        <zip>20109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rebecca Yantz</last_name>
      <phone>877-415-4116</phone>
      <phone_ext>1130</phone_ext>
      <email>ryantz@carient.com</email>
    </contact>
    <investigator>
      <last_name>Aysha Arshad</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Weston</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54479</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Granza</last_name>
      <phone>715-393-1135</phone>
      <email>granza.melissa@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Sanjay Kumar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>January 21, 2023</last_update_submitted>
  <last_update_submitted_qc>January 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 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>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04502316
org study id: 360059-001
nct id: NCT04502316
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this registry is to develop valid scientific evidence of the safety and
      benefit of Barostim Therapy in the commercial setting in patients with heart failure with
      reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Summary:

      The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim
      System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken
      prior to implant, at implant, and every six months after device implant, up to the 36-month
      visit at which time each patient will be exited from the registry.
observational model: Cohort
time perspective: Prospective
measure: Rate of serious adverse events related to the system or implant procedure
time frame: 36 months post-implant
description: Serious adverse events related to the system or implant procedure through 36 months post-implant
measure: Number of heart failure hospitalizations
time frame: 36 months post-implant
description: Number of heart failure hospitalizations through 36 months post-implant
measure: Duration of heart failure hospitalizations
time frame: 36 months post-implant
description: Duration of heart failure hospitalizations through 36 months post-implant
measure: Change NYHA Classification
time frame: 36 months post-implant
description: Changes in NYHA Classification through 36 months post-implant
measure: Change in NT-proBNP
time frame: 36 months post-implant
description: Changes in NT-proBNP through 36 months post-implant
measure: Change in LVEF
time frame: 36 months post-implant
description: Changes in LVEF through 36 months post-implant
measure: Change in Six Minute Hall Walk
time frame: 36 months post-implant
description: Changes in Six Minute Hall Walk distance through 36 months post-implant
intervention type: Device
intervention name: Barostim™ System
description: Implantation of the Barostim™ System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Thomas Deering
role: Study Chair
affiliation: Piedmont Heart Institute
last name: Bradley Knight
role: Study Chair
affiliation: Northwestern Medicine
last name: Larry Chinitz
role: Study Chair
affiliation: NYU Heart Rhythm Center
last name: Michael Gold
role: Study Chair
affiliation: Medical University of South Carolina
last name: Elizabeth Galle
phone: 763-416-2876
email: lgalle@cvrx.com
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country: United States
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No