BAROSTIM NEO System in the Treatment of Heart Failure

Heart Failure Clinical Trial

Official title:

Neo Randomized Heart Failure Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01471860
• Other study ID #: 360029
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: August 11, 2021

Study information

• Verified date: October 2019
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: August 11, 2021
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• BAROSTIM NEO System

Drug:
• Medical Management

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta - Edmonton	Edmonton	Alberta
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Canada	St. Boniface Hospital	Winnipeg	Manitoba
France	CHRU de Lille	Lille
France	CHU de Rennes	Rennes
France	CHU de Toulouse	Toulouse
Germany	Vivantes Hospital Berlin	Berlin
Germany	Immanuel Hospital Bernau-Heart Center Brandenburg	Bernau
Germany	University Hospital Cologne	Cologne
Germany	University Hospital Essen	Essen
Germany	CVC Frankfurt	Frankfurt
Germany	University Hospital Giessen	Giessen
Germany	Georg August University - Goettingen	Göttingen
Germany	Klinik St. Georg, Hamburg	Hamburg
Germany	University Heart Center Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	University Hospital of Schleswig-Holstein, Kiel Campus	Kiel
Germany	Klinikum St. Georg Leipzig	Leipzig
Germany	Klinikum Ludenscheid	Ludenscheid
Germany	University Hospital Mannheim	Mannheim
Germany	Lukas Hospital Neuss	Neuss
Germany	Oldenburg Hospital	Oldenburg
Germany	Reinbek Hospital, St. Adolf-Stift	Reinbek
Italy	Azienda Ospedaliero Universitaria Opedali	Ancona
Italy	Azienda Ospedaliera Spedali Riuniti Di Bergamo	Bergamo
Italy	Azienda Ospedaliero - Universitaria Careggi	Florence
Italy	Istituto Scientifico San Luca	Milan
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Canada,  France,  Germany,  Italy, 

References & Publications (1)

Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-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. JA — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.