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Trial record 1 of 1 for:    NCT02876042
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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 : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this registry (NCT02876042) 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

Detailed Description:

Summary:

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. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility Criteria:

The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:

  • Indications

    • 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
  • Contraindications

    • 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

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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
Actual Study Start Date : March 23, 2017
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: BAROSTIM NEO™ System
    Implantation of the BAROSTIM NEO™ System


Primary Outcome Measures :
  1. Changes in Office Cuff Systolic Blood Pressure [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    Office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.


Secondary Outcome Measures :
  1. Change in New York Heart Association Functional Classification [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    New York Heart Association Classification, if available, should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.

  2. Changes in Left Ventricular Mass Index [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.

  3. Changes in LA volume index [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.

  4. Changes in E/E' ratio [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    An echocardiogram obtained prior to implant, and as close to the implant procedure as possible, will be utilized for the baseline measurement. An additional echocardiogram will be obtained at 3 and 6 months post-implant.

  5. Changes in NT-proBNP [ Time Frame: Pre-implant baseline, 6 months post-implant ]
    If available, measurement should be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.

  6. Evaluate health care utilization over follow-up, such as heart failure hospitalizations [ Time Frame: Pre-implant baseline to 6 months post-implant ]
    Health care utilization information is collected throughout follow-up.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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 pg/mL or BNP > 200 pg/mL) within 30 days prior to enrollment

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
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Contact: Elizabeth Galle 763-416-2876 lgalle@cvrx.com

Locations
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Germany
Berlin Charité & Deutschen Herzzentrum Berlin Active, not recruiting
Berlin, Germany, 12203
Immanuel Klinikum Bernau Herzzentrum Brandenburg Active, not recruiting
Bernau, Germany, 16321
Lippe Klinikum Active, not recruiting
Detmold, Germany, 32756
Uniklinik Frankfurt Active, not recruiting
Frankfurt, Germany, 60590
Universitätsklinikum Gießen und Marburg Recruiting
Gießen, Germany, 35392
Contact: Gabriele Hellwig    +49 641 985 42632    gabriele.hellwig@med.uni-giessen.de   
Principal Investigator: Jörn Schmitt         
Herzzentrum Göttingen Active, not recruiting
Göttingen, Germany, 37075
Asklepios Klinik Altona Recruiting
Hamburg, Germany, 22763
Contact: Christine Neumann    +49 401818818635    chris.neumann@asklepios.com   
Principal Investigator: Jochen Müller-Ehmsen         
Medizinische Hochschule Hannover Active, not recruiting
Hannover, Germany, 30625
Uniklinik Heidelberg Recruiting
Heidelberg, Germany, 69120
Contact: Leonie Grossekettler    +49 6221 563 7758    leonie.grossekettler@med.uni-heidelberg.de   
Principal Investigator: Philip Raake         
Kardiologie im Klinikum Ingolstadt Active, not recruiting
Ingolstadt, Germany, 85049
Universitätsklinikum Köln Herzzentrum Recruiting
Köln, Germany, 50937
Contact: Tatjana Schewior    +49 22147888273    tatjana.schewior@uk-koeln.de   
Principal Investigator: Marcel Halbach         
Universitätsklinikum Regensburg Active, not recruiting
Regensburg, Germany, 93053
Marienkrankenhaus Siegen Active, not recruiting
Siegen, Germany, 57072
Sponsors and Collaborators
CVRx, Inc.
Investigators
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Study Chair: Burkert Pieske, PhD Universitätmedizin Berlin - Charité
Additional Information:
Publications:
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT02876042    
Other Study ID Numbers: 360047-001
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases