Clinical trial NCT01471860: BAROSTIM NEO System in the Treatment of Heart Failure
Official title: Neo Randomized Heart Failure Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-16
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: To assess long-term adverse events in Canadian participants implanted with the BAROSTIM NEO System
timeFrame: For the duration of the study, up to 5 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta - Edmonton
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Lille
country: France
facility: CHRU de Lille
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: CHU de Toulouse
city: Berlin
country: Germany
facility: Vivantes Hospital Berlin
city: Bernau
country: Germany
facility: Immanuel Hospital Bernau-Heart Center Brandenburg
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt
country: Germany
facility: CVC Frankfurt
city: Giessen
country: Germany
facility: University Hospital Giessen
city: Göttingen
country: Germany
facility: Georg August University - Goettingen
city: Hamburg
country: Germany
facility: Klinik St. Georg, Hamburg
city: Hamburg
country: Germany
facility: University Heart Center Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: University Hospital of Schleswig-Holstein, Kiel Campus
city: Leipzig
country: Germany
facility: Klinikum St. Georg Leipzig
city: Ludenscheid
country: Germany
facility: Klinikum Ludenscheid
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Neuss
country: Germany
facility: Lukas Hospital Neuss
city: Oldenburg
country: Germany
facility: Oldenburg Hospital
city: Reinbek
country: Germany
facility: Reinbek Hospital, St. Adolf-Stift
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Opedali
city: Bergamo
country: Italy
facility: Azienda Ospedaliera Spedali Riuniti Di Bergamo
city: Florence
country: Italy
facility: Azienda Ospedaliero - Universitaria Careggi
city: Milan
country: Italy
facility: Istituto Scientifico San Luca
Study officials:
affiliation: University of Cologne
name: Uta Hoppe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.