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BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction (HFpEF)

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ClinicalTrials.gov Identifier: NCT02876042
Recruitment Status : Recruiting
First Posted : August 23, 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 that also have evidence of heart failure with preserved ejection fraction (HFpEF).

Condition or disease Intervention/treatment
Heart Failure Device: BAROSTIM NEO™ System

Study Type : Observational [Patient Registry]
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Office Cuff Systolic Blood Pressure Changes from Baseline to 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]

Secondary Outcome Measures :
  1. Change in New York Heart Association Functional Classification at 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
  2. Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months ]
  3. Biomarkers [ Time Frame: Pre-implant baseline, 3 and 6 months ]
    NT-pro-BNP and other biomarkers of end organ damage routinely collected as standard of care

  4. 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
The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria.
Criteria

Inclusion Criteria:

  • Sign an Ethics Committee (EC) approved informed consent form for the registry.
  • Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.
  • BAROSTIM THERAPY not yet chronically activated.
  • Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.
  • On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.
  • Objective evidence of heart failure according to the following criteria:

    • Hospitalization for heart failure within 12 months prior to enrollment OR
    • Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 30 days prior to enrollment OR
    • NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600

Exclusion Criteria:

  • Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
  • Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

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): NCT02876042


Contacts
Contact: Liz Galle 763-416-2876

Locations
Germany
Immanual Kilikum Bernau Recruiting
Bernau, Germany, 16321
Contact: Daniela Bettin    +49-3338-694604    d.bettin@immanuel.de   
Principal Investigator: Christian Butter         
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         
University of Cologne Recruiting
Koln, Germany, 50937
Contact: Tatjana Schewior    49-221-478-88273    tatjana.schewior@uk-koeln.de   
Principal Investigator: Marcel Halbach         
Marien-Krankenhaus Seigen gem. GmbH Recruiting
Siegen, Germany, 57072
Contact: Christopher Blanke    02711-231-1215    c.blanke@marienkrankenhaus.com   
Principal Investigator: Michael Buerke         
Sponsors and Collaborators
CVRx, Inc.
Investigators
Study Chair: Burkert Pieske, PhD Universitätmedizin Berlin - Charité

Publications:
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02876042     History of Changes
Other Study ID Numbers: 360047-001
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Keywords provided by CVRx, Inc.:
Heart Failure
Preserved Ejection Fraction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases