NCT01471860

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable heart-failure

Geographic Reach
4 countries

30 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
6.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 11, 2021

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

3.1 years

First QC Date

November 9, 2011

Last Update Submit

October 31, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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.

    For the duration of the study, up to 5 years.

Study Arms (1)

Device and Medical Management

EXPERIMENTAL

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.

Device: BAROSTIM NEO SystemDrug: Medical Management

Interventions

BAROSTIM NEO SystemDEVICE
Also known as: XR-1 System, Neo System
Device and Medical Management
Medical ManagementDRUG
Device and Medical Management

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta - Edmonton

Edmonton, Alberta, T6G 2B7, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

CHRU de Lille

Lille, 590347, France

Location

CHU de Rennes

Rennes, 35033, France

Location

CHU de Toulouse

Toulouse, 31073, France

Location

Vivantes Hospital Berlin

Berlin, 10967, Germany

Location

Immanuel Hospital Bernau-Heart Center Brandenburg

Bernau, 16321, Germany

Location

University Hospital Cologne

Cologne, 50937, Germany

Location

University Hospital Essen

Essen, 45122, Germany

Location

CVC Frankfurt

Frankfurt, 60389, Germany

Location

University Hospital Giessen

Giessen, 35392, Germany

Location

Georg August University - Goettingen

Göttingen, 37075, Germany

Location

Klinik St. Georg, Hamburg

Hamburg, 20099, Germany

Location

University Heart Center Hamburg

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

University Hospital of Schleswig-Holstein, Kiel Campus

Kiel, 24105, Germany

Location

Klinikum St. Georg Leipzig

Leipzig, 04129, Germany

Location

Klinikum Ludenscheid

Lüdenscheid, 58515, Germany

Location

University Hospital Mannheim

Mannheim, 68167, Germany

Location

Lukas Hospital Neuss

Neuss, 41464, Germany

Location

Oldenburg Hospital

Oldenburg, 26133, Germany

Location

Reinbek Hospital, St. Adolf-Stift

Reinbek, 21465, Germany

Location

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Azienda Ospedaliero Universitaria Opedali

Ancona, 60126, Italy

Location

Azienda Ospedaliera Spedali Riuniti Di Bergamo

Bergamo, 24128, Italy

Location

Azienda Ospedaliero - Universitaria Careggi

Florence, 50134, Italy

Location

Istituto Scientifico San Luca

Milan, 20149, Italy

Location

Related Publications (3)

  • 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.

    PMID: 25982108RESULT

  • 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.

    PMID: 29705650DERIVED

  • 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.

    PMID: 26011593DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Practice ManagementProfessional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Uta Hoppe, MD

    University of Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2011

First Posted

November 16, 2011

Study Start

August 1, 2011

Primary Completion

September 1, 2014

Study Completion

August 11, 2021

Last Updated

November 4, 2019

Record last verified: 2019-10

Locations

DE(17)IT(5)FR(3)CA(5)