search
Back to results

BAROSTIM NEO System in the Treatment of Heart Failure

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BAROSTIM NEO System
Medical Management
Sponsored by
CVRx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Calgary
  • University of Alberta - Edmonton
  • University of British Columbia
  • St. Boniface Hospital
  • Montreal Heart Institute
  • CHRU de Lille
  • CHU de Rennes
  • CHU de Toulouse
  • Vivantes Hospital Berlin
  • Immanuel Hospital Bernau-Heart Center Brandenburg
  • University Hospital Cologne
  • University Hospital Essen
  • CVC Frankfurt
  • University Hospital Giessen
  • Georg August University - Goettingen
  • Klinik St. Georg, Hamburg
  • University Heart Center Hamburg
  • Medizinische Hochschule Hannover
  • University Hospital of Schleswig-Holstein, Kiel Campus
  • Klinikum St. Georg Leipzig
  • Klinikum Ludenscheid
  • University Hospital Mannheim
  • Lukas Hospital Neuss
  • Oldenburg Hospital
  • Reinbek Hospital, St. Adolf-Stift
  • Istituto Clinico Humanitas
  • Azienda Ospedaliero Universitaria Opedali
  • Azienda Ospedaliera Spedali Riuniti Di Bergamo
  • Azienda Ospedaliero - Universitaria Careggi
  • Istituto Scientifico San Luca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device and Medical Management

Arm Description

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.

Outcomes

Primary Outcome Measures

To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
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.

Secondary Outcome Measures

Full Information

First Posted
November 9, 2011
Last Updated
October 31, 2019
Sponsor
CVRx, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01471860
Brief Title
BAROSTIM NEO System in the Treatment of Heart Failure
Official Title
Neo Randomized Heart Failure Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
August 11, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CVRx, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device and Medical Management
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BAROSTIM NEO System
Other Intervention Name(s)
XR-1 System, Neo System
Intervention Type
Drug
Intervention Name(s)
Medical Management
Primary Outcome Measure Information:
Title
To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
Description
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.
Time Frame
For the duration of the study, up to 5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uta Hoppe, MD
Organizational Affiliation
University of Cologne
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta - Edmonton
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
CHRU de Lille
City
Lille
ZIP/Postal Code
590347
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31073
Country
France
Facility Name
Vivantes Hospital Berlin
City
Berlin
ZIP/Postal Code
10967
Country
Germany
Facility Name
Immanuel Hospital Bernau-Heart Center Brandenburg
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
University Hospital Cologne
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
University Hospital Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
CVC Frankfurt
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
University Hospital Giessen
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Georg August University - Goettingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinik St. Georg, Hamburg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
University Heart Center Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
University Hospital of Schleswig-Holstein, Kiel Campus
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum St. Georg Leipzig
City
Leipzig
ZIP/Postal Code
04129
Country
Germany
Facility Name
Klinikum Ludenscheid
City
Ludenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
University Hospital Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Lukas Hospital Neuss
City
Neuss
ZIP/Postal Code
41464
Country
Germany
Facility Name
Oldenburg Hospital
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Reinbek Hospital, St. Adolf-Stift
City
Reinbek
ZIP/Postal Code
21465
Country
Germany
Facility Name
Istituto Clinico Humanitas
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Opedali
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Riuniti Di Bergamo
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
Facility Name
Azienda Ospedaliero - Universitaria Careggi
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Istituto Scientifico San Luca
City
Milan
ZIP/Postal Code
20149
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
25982108
Citation
Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-496. doi: 10.1016/j.jchf.2015.02.006. Epub 2015 May 14.
Results Reference
result
PubMed Identifier
29705650
Citation
Halbach M, Abraham WT, Butter C, Ducharme A, Klug D, Little WC, Reuter H, Schafer JE, Senni M, Swarup V, Wachter R, Weaver FA, Wilks SJ, Zile MR, Muller-Ehmsen J. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018 Sep 1;266:187-192. doi: 10.1016/j.ijcard.2018.04.075. Epub 2018 Apr 21.
Results Reference
derived
PubMed Identifier
26011593
Citation
Zile MR, Abraham WT, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Muller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiac resynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. doi: 10.1002/ejhf.299. Epub 2015 Jun 10.
Results Reference
derived

Learn more about this trial

BAROSTIM NEO System in the Treatment of Heart Failure

We'll reach out to this number within 24 hrs