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BAROSTIM THERAPY™ In Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT02880631
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this registry is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO System in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension.

Condition or disease Intervention/treatment
Hypertension Device: Barostim Neo™ System

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: BAROSTIM THERAPY™ In Resistant Hypertension: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study Start Date : August 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Blood Pressure Changes from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
  2. Cardiovascular Medication Changes from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
    Medication name, dose, frequency, and start/stop date will be assessed over the 6 month time interval.

  3. Number of Hospitalizations over Follow-Up [ Time Frame: 12 months post-implant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects can be included in the Hypertension Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications and contraindications for the BAROSTIM NEO System in the treatment of resistant hypertension.
Criteria

Inclusion Criteria:

  • Has signed an EC approved informed consent form
  • Has been implanted with the BAROSTIM NEO system in the past 30 days
  • Systolic blood pressure greater than or equal to 140 mmHg, and
  • Resistance to maximally tolerated therapy with a diuretic and two other anti-hypertension medications

Exclusion Criteria:

  • Bilateral carotid bifurcations located above the level of the mandible
  • Baroreflex failure or autonomic neuropathy
  • Uncontrolled, symptomatic cardiac bradyarrhythmias
  • Carotid atherosclerosis that is determined by ultrasound or angiographic evaluation to be greater than 50%
  • Ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880631


Contacts
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Contact: CVRx Vice President of Clinical Research 763-416-2876

Locations
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Germany
Immanual Kilikum Bernau Recruiting
Bernau, Germany, 16321
Contact: Daniela Bettin    +49-3338-694604    d.bettin@immanuel.de   
Principal Investigator: Christian Butter         
St. Josefs-Hospital Cloppenburg gemainnutzige gGmbH Recruiting
Cloppenburg, Germany, 49661
Contact: Ulla Venneklaas    +49 4471-16 2955    ulla.venneklaas@kk-om.de   
Principal Investigator: Stephan Luders         
Cardiovascular Center 'CVC' Frankfurt Recruiting
Frankfurt, Germany, 60398
Contact: Sabine De Bruijn    +49 69 97347653    s.debruijn@cvcfrankfurt.de   
Principal Investigator: Horst Sievert         
Justus-Leibig University Giessen Recruiting
Gießen, Germany, 35392
Contact: Gabriele Hellwig    0641-985-42632    gabriele.hellwig@med.uni-giessen.de   
Principal Investigator: Jorn Schmitt         
Hamburg - Asklepios Kliniken Recruiting
Hamburg, Germany, 20099
Contact: Christine Neumann    +49 401818818635    chris.neumann@asklepios.com   
Principal Investigator: Jochen Muller-Ehmsen         
Schleswig-Hostein Campus Kiel Recruiting
Kiel, Germany, 24105
Contact: Anika Struve    +49-431-500-22915    anika.struve@uksh.de   
Principal Investigator: Hendrik Bonnemeier         
University Hospital of Cologne Recruiting
Köln, Germany, 50937
Contact: Tatjana Schewior    +49-221-478-88273    Tatjana.schewior@uk-koeln.de   
Principal Investigator: Hannes Reuter         
Universitat Leipzig Recruiting
Leipzig, Germany, 04109
Contact: Jenny Dietrich    +49 (341) 97 12 408    jenny.dietrich@medizin.uni-leipzig.de   
Contact: Janine Starke    +49 (341) 97 12 443f    janine.starke@medizin.uni-leipzig.de   
Principal Investigator: Martin Neef         
Kilnikum Lippe GmbH Recruiting
Lippe, Germany, 32756
Contact: Melanie Kriete    05231 172-5727    melanie.kriete@klinikum-lippe.de   
Principal Investigator: Kirk Haertel         
Marien-Krankenhaus Seigen gem. GmbH Recruiting
Siegen, Germany, 57072
Contact: Christopher Blanke    02711-231-1215    c.blanke@marienkrankenhaus.com   
Principal Investigator: Michael Buerke         
Hospital and MVS Maria-Hilf Stadtlohn GmbH Recruiting
Stadtlohn, Germany, 489703
Contact: Britta Fitz    02563-912-6370    b.fitz@kmh-stadtlohn.de   
Principal Investigator: Alessandro Cuneo         
Klinikum Landkreis Tuttlingen Recruiting
Tuttlingen, Germany, 78532
Contact: Ida Weber    07461 97 1415    i.weber@klinikum-tut.de   
Principal Investigator: Michael Kotzerke         
Heinrich-Braun Klinikum Recruiting
Zwickau, Germany, 08060
Contact: Heike Plottner    0375512138    heike.ploettner@hbk-zwickau.de   
Principal Investigator: Jens Gerth         
Netherlands
Clinical Trial Center Maastricht, B.V. Recruiting
Maastricht, Netherlands, 6229
Contact: Heidi Jongen    +31-43-3877366    h.jongen@mumc.nl   
Principal Investigator: Bram Kroon         
Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Hannes Reuter, PhD Herzzentrum Uniklinik Köln

Additional Information:

Publications:
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02880631     History of Changes
Other Study ID Numbers: 360051-001
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases