BAROSTIM NEO System in the Treatment of Heart Failure

October 31, 2019 updated by: CVRx, Inc.

Neo Randomized Heart Failure Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Actively participating in the Neo Randomized Heart Failure Study.
  • Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Device and Medical Management

Medical Management, to be determined by the participant's physician, described as:

  • Optimal pharmacological therapy: Prescribed to a beta blocker, a diuretic, and an ACE (Angiotensin-converting-enzyme) inhibitor or ARB (Angiotensin Receptor Blocker) unless contraindicated or not tolerated. These drugs must be used in a manner consistent with their labeling.
  • Stable pharmacological therapy: No more than a 50% increase or a 50% decrease of the dosage of any one medication, and post titration of all heart failure medications.

Participants should remain on their prescribed heart failure medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.
Drug: Medical Management
Device: BAROSTIM NEO System
Other Names:
  • XR-1 System
  • Neo System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
Time Frame: For the duration of the study, up to 5 years.
Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with the BAROSTIM NEO System.
For the duration of the study, up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Principal Investigator: Uta Hoppe, MD, University of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2011

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ANTICIPATED)

August 11, 2021

Study Registration Dates

First Submitted

November 9, 2011

First Submitted That Met QC Criteria

November 10, 2011

First Posted (ESTIMATE)

November 16, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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