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Barostim Neo System in the Treatment of Heart Failure

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ClinicalTrials.gov Identifier: NCT01471860
Recruitment Status : Completed
First Posted : November 16, 2011
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Brief Summary:
The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Barostim Neo System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neo Randomized Heart Failure Study
Actual Study Start Date : August 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Device group
Barostim Neo System
Device: Barostim Neo System
Baroreflex Activation Therapy using the Barostim Neo System
Other Name: XR-1 System

No Intervention: Medical Management group
Medical Management therapy



Primary Outcome Measures :
  1. Change from baseline in Left Ventricular Ejection Fraction at 6 months. [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age at least 21 years
  • Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria:

  • Significant carotid plaque or stenosis
  • Known or suspected baroreflex failure or autonomic neuropathy
  • Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
  • Heart failure secondary to a reversible condition

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): NCT01471860


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 4Z6
University of Alberta - Edmonton
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Manitoba
St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
France
CHRU de Lille
Lille, France, 590347
CHU de Rennes
Rennes, France, 35033
CHU de Toulouse
Toulouse, France, 31073
Germany
Vivantes Hospital Berlin
Berlin, Germany, 10967
Immanuel Hospital Bernau-Heart Center Brandenburg
Bernau, Germany, 16321
University Hospital Cologne
Cologne, Germany, 50937
University Hospital Essen
Essen, Germany, 45122
CVC Frankfurt
Frankfurt, Germany, 60389
University Hospital Giessen
Giessen, Germany, 35392
Georg August University - Goettingen
Göttingen, Germany, 37075
Klinik St. Georg, Hamburg
Hamburg, Germany, 20099
University Heart Center Hamburg
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
University Hospital of Schleswig-Holstein, Kiel Campus
Kiel, Germany, 24105
Klinikum St. Georg Leipzig
Leipzig, Germany, 04129
Klinikum Ludenscheid
Ludenscheid, Germany, 58515
University Hospital Mannheim
Mannheim, Germany, 68167
Lukas Hospital Neuss
Neuss, Germany, 41464
Oldenburg Hospital
Oldenburg, Germany, 26133
Reinbek Hospital, St. Adolf-Stift
Reinbek, Germany, 21465
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Azienda Ospedaliero Universitaria Opedali
Ancona, Italy, 60126
Azienda Ospedaliera Spedali Riuniti Di Bergamo
Bergamo, Italy, 24128
Azienda Ospedaliero - Universitaria Careggi
Florence, Italy, 50134
Istituto Scientifico San Luca
Milan, Italy, 20149
Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Uta Hoppe, MD University of Cologne

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01471860     History of Changes
Other Study ID Numbers: 360029
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases