BAROSTIM NEO System in the Treatment of Heart Failure

Not Applicable

• Conditions: Heart Failure
• Interventions: Device: BAROSTIM NEO System; Drug: Medical Management

• Registration Number: NCT01471860
• Lead Sponsor: CVRx, Inc.

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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Primary Completion: 2014-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-31
• Last Update Posted: 2019-11-04
• Study Completion: 2021-08-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device and Medical Management	BAROSTIM NEO System	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 and Medical Management	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.

Primary Outcome Measures

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

Trial Locations

Locations (30)

St. Boniface Hospital; 🇨🇦 Winnipeg, Manitoba, Canada

Vivantes Hospital Berlin; 🇩🇪 Berlin, Germany

Immanuel Hospital Bernau-Heart Center Brandenburg; 🇩🇪 Bernau, Germany

CHU de Toulouse; 🇫🇷 Toulouse, France

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

Azienda Ospedaliera Spedali Riuniti Di Bergamo; 🇮🇹 Bergamo, Italy

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

University Hospital Mannheim; 🇩🇪 Mannheim, Germany

Lukas Hospital Neuss; 🇩🇪 Neuss, Germany

Reinbek Hospital, St. Adolf-Stift; 🇩🇪 Reinbek, Germany

Azienda Ospedaliero Universitaria Opedali; 🇮🇹 Ancona, Italy

Oldenburg Hospital; 🇩🇪 Oldenburg, Germany

Azienda Ospedaliero - Universitaria Careggi; 🇮🇹 Florence, Italy

Klinikum Ludenscheid; 🇩🇪 Ludenscheid, Germany

CHRU de Lille; 🇫🇷 Lille, France

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Istituto Scientifico San Luca; 🇮🇹 Milan, Italy

CHU de Rennes; 🇫🇷 Rennes, France

Montreal Heart Institute; 🇨🇦 Montreal, Quebec, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Alberta - Edmonton; 🇨🇦 Edmonton, Alberta, Canada