BAROSTIM NEO System in the Treatment of Heart Failure

NCT ID: NCT01471860

Last Updated: 2019-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2021-08-11

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

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Device and 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.

Group Type: EXPERIMENTAL

BAROSTIM NEO System

Intervention Type: DEVICE

Medical Management

Intervention Type: DRUG

Interventions

BAROSTIM NEO System

Intervention Type: DEVICE

Medical Management

Intervention Type: DRUG

Other Intervention Names

XR-1 System; Neo System

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CVRx, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Uta Hoppe, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta - Edmonton

Edmonton, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

St. Boniface Hospital

Winnipeg, Manitoba, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

CHRU de Lille

Lille, , France

CHU de Rennes

Rennes, , France

CHU de Toulouse

Toulouse, , France

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

Hanover, , Germany

University Hospital of Schleswig-Holstein, Kiel Campus

Kiel, , Germany

Klinikum St. Georg Leipzig

Leipzig, , Germany

Klinikum Ludenscheid

Lüdenscheid, , Germany

University Hospital Mannheim

Mannheim, , Germany

Lukas Hospital Neuss

Neuss, , Germany

Oldenburg Hospital

Oldenburg, , Germany

Reinbek Hospital, St. Adolf-Stift

Reinbek, , Germany

Istituto Clinico Humanitas

Rozzano, Milano, 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

Countries

Canada; France; Germany; Italy

References

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.

Reference Type: RESULT

PMID: 25982108 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29705650 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 26011593 (View on PubMed)

Other Identifiers

360029

Identifier Type: -

Identifier Source: org_study_id