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Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
Sponsor: Boston Scientific Corporation
Summary
The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.
Official title: Neural Cardiac Therapy for Heart Failure Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
118
Start Date
2011-09-21
Completion Date
2026-06-30
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (21)
UCL Bruxelles
Brussels, Belgium
Nemocnice Na Homolce
Prague, Czechia
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
Vandœuvre-lès-Nancy, Nancy, France
CHRU de Lille - Hôpital Cardiologique
Lille, France
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Azienda Ospedaliera Niguarda Cà Granda
Milan, Italy
A. O. Dei Colli - Monaldi
Naples, Italy
Policlinico San Matteo
Pavia, Italy
Catharina Ziekenhuis Eindhoven
Eindhoven, Netherlands
UMC Utrecht
Utrecht, Netherlands
Clínica Universitaria de Navarra, Avenida Pio XII s/n
Pamplona, Navarre, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Doce de Octubre
Madrid, Spain
University Hospitals Bristol, NHS Foundation Trust
Bristol, England, United Kingdom
Liverpool Heart and Chest Hospital, NHS Foundation Trust
Liverpool, England, United Kingdom
The Heart Hospital, University College London Hospitals, NHS Foundation Trust
London, England, United Kingdom
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom