BAROSTIM NEO System in the Treatment of Heart Failure

Last updated: October 31, 2019
Sponsor: CVRx, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Congestive Heart Failure

Chest Pain

Hyponatremia

Treatment

N/A

Clinical Study ID

NCT01471860
360029
  • Ages > 21
  • All Genders

Study Summary

The purpose of this portion of study NCT01471860 is to assess the long-term safety and efficacy of the BAROSTIM NEO System in Canadian study participants implanted with the device.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Actively participating in the Neo Randomized Heart Failure Study.

  • Have signed a revised approved informed consent form for continued participation inthis study.

Exclusion

Exclusion Criteria:

  • Treating physician decision that the subject should not continue with therapy.

Study Design

Total Participants: 94
Study Start date:
August 01, 2011
Estimated Completion Date:
August 11, 2021

Study Description

The Neo Randomized Heart Failure Study is a prospective, randomized, study describing the safety and efficacy of the BAROSTIM NEO System in the heart failure participants with a left ventricular ejection fraction ≤ 35%.

During long-term follow-up, all participants are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

  • Physical Assessment

  • Subject Medications

  • Serious adverse events

Connect with a study center

  • Salzburg University Hospital

    Salzburg, A-5020
    Austria

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • University of Alberta - Edmonton

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of British Columbia

    Vancouver, British Columbia V6Z 1Y6
    Canada

    Site Not Available

  • St. Boniface Hospital

    Winnipeg, Manitoba R2H 2A6
    Canada

    Site Not Available

  • Lawson Health Research Institute

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • University of Toronto - Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Montreal Heart Institute

    Montreal, Quebec H1T 1C8
    Canada

    Site Not Available

  • CHRU de Lille

    Lille, 590347
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Site Not Available

  • CHU de Toulouse

    Toulouse, 31073
    France

    Site Not Available

  • Vivantes Hospital Berlin

    Berlin, 10967
    Germany

    Site Not Available

  • Immanuel Hospital Bernau-Heart Center Brandenburg

    Bernau, 16321
    Germany

    Site Not Available

  • University Hospital Cologne

    Cologne, 50937
    Germany

    Site Not Available

  • University Hospital Essen

    Essen, 45122
    Germany

    Site Not Available

  • CVC Frankfurt

    Frankfurt, 60389
    Germany

    Site Not Available

  • University Hospital Giessen

    Giessen, 35392
    Germany

    Site Not Available

  • Georg August University - Goettingen

    Goettingen, 37075
    Germany

    Site Not Available

  • Georg August University - Goettingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Klinik St. Georg, Hamburg

    Hamburg, 20099
    Germany

    Site Not Available

  • University Heart Center Hamburg

    Hamburg, 20246
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • University Hospital of Saarland, Homburg Campus

    Homburg, 66421
    Germany

    Site Not Available

  • University Hospital of Schleswig-Holstein, Kiel Campus

    Kiel, 24105
    Germany

    Site Not Available

  • Klinikum St. Georg Leipzig

    Leipzig, 04129
    Germany

    Site Not Available

  • University Hospital of Schleswig-Holstein, Lubeck Campus

    Lubeck, 23538
    Germany

    Site Not Available

  • Klinikum Ludenscheid

    Ludenscheid, 58515
    Germany

    Site Not Available

  • University Hospital Mannheim

    Mannheim, 68167
    Germany

    Site Not Available

  • Lukas Hospital Neuss

    Neuss, 41464
    Germany

    Site Not Available

  • Oldenburg Hospital

    Oldenburg, 26133
    Germany

    Site Not Available

  • Reinbek Hospital, St. Adolf-Stift

    Reinbek, 21465
    Germany

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Opedali

    Ancona, 60126
    Italy

    Site Not Available

  • Azienda Ospedaliera Spedali Riuniti Di Bergamo

    Bergamo, 24128
    Italy

    Site Not Available

  • Azienda Ospedaliero - Universitaria Careggi

    Florence, 50134
    Italy

    Site Not Available

  • Istituto Scientifico San Luca

    Milan, 20149
    Italy

    Site Not Available

  • Clinica San Gaudenzio

    Novara,
    Italy

    Site Not Available

  • Maastricht University

    Maastricht, 6229 HX
    Netherlands

    Site Not Available

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