118
Participants
Start Date
September 21, 2011
Primary Completion Date
May 31, 2014
Study Completion Date
June 30, 2026
Implant of investigational device system
Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.
Titration during the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.
Titration after the randomization phase
Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.
Blood Draw
Blood draw before implant and 6 months after implant at the end of the randomization phase.
UCL Bruxelles, Brussels
Nemocnice Na Homolce, Prague
Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau bei Berlin
Azienda Ospedaliera Niguarda Cà Granda, Milan
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf, Hamburg
Policlinico San Matteo, Pavia
Hospital Doce de Octubre, Madrid
Clínica Universitaria de Navarra, Avenida Pio XII s/n, Pamplona
Universitätsmedizin Göttingen, Göttingen
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy, Vandœuvre-lès-Nancy
CHRU de Lille - Hôpital Cardiologique, Lille
A. O. Dei Colli - Monaldi, Napoli
Universitätsklinikum Leipzig, Leipzig
Catharina Ziekenhuis Eindhoven, Eindhoven
UMC Utrecht, Utrecht
Hospital Clinic de Barcelona, Barcelona
University Hospitals Bristol, NHS Foundation Trust, Bristol
Liverpool Heart and Chest Hospital, NHS Foundation Trust, Liverpool
The Heart Hospital, University College London Hospitals, NHS Foundation Trust, London
Imperial College Healthcare NHS Trust, St. Mary's Hospital, London
King's College Hospital NHS Foundation Trust, London
Lead Sponsor
Boston Scientific Corporation
INDUSTRY