BAROSTIM NEO System in the Treatment of Heart Failure
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
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.
Sites / Locations
- University of Calgary
- University of Alberta - Edmonton
- University of British Columbia
- St. Boniface Hospital
- Montreal Heart Institute
- CHRU de Lille
- CHU de Rennes
- CHU de Toulouse
- Vivantes Hospital Berlin
- Immanuel Hospital Bernau-Heart Center Brandenburg
- University Hospital Cologne
- University Hospital Essen
- CVC Frankfurt
- University Hospital Giessen
- Georg August University - Goettingen
- Klinik St. Georg, Hamburg
- University Heart Center Hamburg
- Medizinische Hochschule Hannover
- University Hospital of Schleswig-Holstein, Kiel Campus
- Klinikum St. Georg Leipzig
- Klinikum Ludenscheid
- University Hospital Mannheim
- Lukas Hospital Neuss
- Oldenburg Hospital
- Reinbek Hospital, St. Adolf-Stift
- Istituto Clinico Humanitas
- Azienda Ospedaliero Universitaria Opedali
- Azienda Ospedaliera Spedali Riuniti Di Bergamo
- Azienda Ospedaliero - Universitaria Careggi
- Istituto Scientifico San Luca
Arms of the Study
Arm 1
Experimental
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.