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BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction (HFrEF)

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ClinicalTrials.gov Identifier: NCT02880618
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 heart failure with reduced ejection fraction (HFrEF).

Condition or disease Intervention/treatment
Heart Failure 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: 12 Months
Official Title: BAROSTIM THERAPY™ in Heart Failure With Reduced Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Change in New York Heart Association Functional Classification at 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
  2. Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
  3. Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
  4. Change in Biomarkers from Baseline to 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
    e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C

  5. 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 Heart Failure with Reduced Ejection Fraction Registry if they were implanted in the past 30 days and meet the CE-Mark approved indications, and are not contraindicated, for the BAROSTIM NEO System in the treatment of heart failure.
Criteria

Inclusion Criteria:

  • Has signed an EC approved informed consent form
  • Has been treated with the appropriate heart failure guideline directed therapy
  • Has been implanted with the BAROSTIM NEO System in the past 30 days
  • NYHA III and,
  • LVEF ≤ 35%

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): NCT02880618


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

Locations
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Germany
Bad Oeynhausen Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Birgct Wellmann    05721-973327    Bwellmann@hdz-nrw.de   
Principal Investigator: Klaus-Jurgen Gutleben         
Immanuel Klinikum Bernau Recruiting
Bernau, Germany, 16321
Contact: Daniela Bettin    +49-3338-694604    d.bettin@immanuel.de   
Principal Investigator: Christian Butter         
MVZ am Kuchwald GmbH Recruiting
Chemnitz, Germany, 09113
Contact: Felicitas Fröhlich-Grimm    + 49 371 37421354    f.froehlich-grimm@herzcentrum-chemnitz.de   
Principal Investigator: Wilfried Danschel         
Justus-Leibig University Giessen Recruiting
Gießen, Germany, 35392
Contact: Gabriele Hellwig    0641-985-42632    gabriele.hellwig@med.uni-giessen.de   
Principal Investigator: Jorn Schmitt         
Asklepios Kliniken Hamburg GmbH Recruiting
Hamburg, Germany, 20099
Contact: Christine Neumann    +49 401818818635    chris.neumann@asklepios.com   
Principal Investigator: Jochen Müller-Ehmsen         
Albertinen-Krankenhaus Recruiting
Hamburg, Germany, 22457
Contact: Cramer Eva    0049-40-55886722    eva.cramer@albertinen.de   
Principal Investigator: Nagele Herbert         
Medizinische Hoschshule Hannover Recruiting
Hannover, Germany, 30625
Contact: Antje Juergens    +49 511/ 532 6054    juergens.antje@mh-hannover.de   
Principal Investigator: Christian Veltmann         
Universitatsklinikum Schleswig Holstein, 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
Koln, Germany, 50937
Contact: Tatjana Schewior    49-221-478-88273    Tatjana.schewior@uk-koeln.de   
Principal Investigator: Marcel Halbach         
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 12 443    janine.starke@medizin.uni-leipzig.de   
Principal Investigator: Martin Neef         
Klinikum St. Georg gGmbH Recruiting
Leipzig, Germany, 04129
Contact: Susanne Reichelt    03419094561    susanne.reichelt@sanktgeorg.de   
Principal Investigator: Norbert Klein         
Marien-Krankenhaus Siegen gem. GmbH Recruiting
Siegen, Germany, 57072
Contact: Christoph 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         
Italy
Fondazione di Ricerca e Cura "Giovanni Paolo II" Recruiting
Campobasso, Italy, 86100
Contact: Celestino Sardu    +39 0874-312361    drsarducele@gmail.com   
Principal Investigator: Eugenio Caradonna         
Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Jochen Müller-Ehmsen, PhD Asklepios Klinik Altona

Additional Information:

Publications:
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02880618     History of Changes
Other Study ID Numbers: 360049-001
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by CVRx, Inc.:
Heart Failure
Reduced ejection fraction

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases