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Trial record 1 of 1 for:    NCT02880618
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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 : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this registry (NCT02880618) 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

Detailed Description:

Summary:

The CVRx BAROSTIM THERAPY in Heart Failure with Reduced Ejection Fraction (HFrEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for heart failure. Subjects must be enrolled within 30 days from implant. Up to 500 subjects will be enrolled at up to 50 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3, 6, and 12 months after the device was implanted, at which time each subject will be exited from the registry.

Eligibility:

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. The BAROSTIM NEO System is indicated for subjects with heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy.

The contraindications are:

  • 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

Objectives:

To describe change in the following measures at 3, 6 and 12 months compared to pre-implant baseline:

  • New York Heart Association (NYHA) Class
  • Six Minute Hall Walk
  • Echocardiogram measures
  • Biomarkers (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C).

Evaluate health care utilization over follow-up, such as heart failure hospitalizations.

Describe device programming and utilization

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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
Actual Study Start Date : December 13, 2016
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




Primary Outcome Measures :
  1. Change in New York Heart Association Functional Classification at 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
    To demonstrate that that treatment with BAROSTIM NEO improves New York Heart Association classification.

  2. Change in Six Minute Hall Walk from Baseline to 6 months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
    To demonstrate that that treatment with BAROSTIM NEO improves six-minute hall walk performance.

  3. Left Ventricular Mass Index Change from Baseline to 6 Months Post-Implant [ Time Frame: Baseline, 6 months post-implant ]
    To demonstrate that that treatment with BAROSTIM NEO reduces left ventricular mass index.

  4. Change in Biomarkers from Baseline to 6 months Post-Implant (e.g. NT-pro BNP, eGFR, Troponin HsT, Cystatin C) [ Time Frame: Baseline, 6 months post-implant ]
    To demonstrate that that treatment with BAROSTIM NEO improves biomarker results.

  5. Number of Hospitalizations over Follow-Up [ Time Frame: 12 months post-implant ]
    To demonstrate that that treatment with BAROSTIM NEO reduces hospitalizations.



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:   Non-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:

  • Subject has heart failure, defined as New York Heart Association (NYHA) functional Class III and left ventricular ejection fraction (LVEF) ≤ 35% despite being treated with the appropriate heart failure guideline directed therapy
  • Subject has been implanted with the BAROSTIM NEO System in the past 30 days
  • Subject has signed an Ethics Committee approved informed consent form

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

Locations
Show Show 30 study locations
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    
Other Study ID Numbers: 360049-001
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases