Trial record 1 of 1 for:    NCT01471860
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Barostim Neo System in the Treatment of Heart Failure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01471860
First received: November 9, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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 Intervention
Heart Failure
Device: Barostim Neo System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neo Randomized Heart Failure Study

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • Change from baseline in Left Ventricular Ejection Fraction at 6 months. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
Goettingen, Germany, 37075
University Heart Center Hamburg
Hamburg, Germany, 20246
Klinik St. Georg, Hamburg
Hamburg, Germany, 20099
Medizinische Hochschule Hannover
Hannover, Germany, 30625
University Hospital of Saarland, Homburg Campus
Homburg, Germany, 66421
University Hospital of Schleswig-Holstein, Kiel Campus
Kiel, Germany, 24105
Klinikum St. Georg Leipzig
Leipzig, Germany, 04129
University Hospital of Schleswig-Holstein, Lubeck Campus
Lubeck, Germany, 23538
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
Istituto Scientifico San Luca
Milan, Italy, 20149
Netherlands
Maastricht University
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
CVRx, Inc.
Investigators
Principal Investigator: Uta Hoppe, MD University of Cologne
  More Information

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01471860     History of Changes
Other Study ID Numbers: 360029
Study First Received: November 9, 2011
Last Updated: April 11, 2014
Health Authority: Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Italy: Ministry of Health
Austria: Federal Office for Safety in Health Care
Switzerland: Federal Office of Public Health

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014