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.
The objectives of this study are to assess the impact of right vagal nerve stimulation on left ventricular remodeling, functional capacity, quality of life, and other measures in heart failure patients over a 6-month period. In addition, the study will assess the safety of the NECTAR-HF study system over an 18-month period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
118
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.
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.
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.
UCL Bruxelles
Brussels, Belgium
Change in Left Ventricular End-systolic Dimension (LVESD)
Change in the Left ventricular end-systolic dimension (LVESD) between Baseline and the value at the end of the randomization phase (6 months after Baseline) i.e. 6 months after vagus nerve stimulation in the THERAPY Arm. No Vagus nerve stimulation during that time window in the CONTROL Arm. The sign (- ) indicates a reduction in the LVESD. Minus means a reduction in LVESD. The change was calculated from two time points as the value at the later time point minus the value at the earlier time point (e.g., value at 6 months minus value at baseline).
Time frame: LVESD at Baseline and at 6-months post Baseline
Percentage of Surviving Participants
As pre-specified in the study protocol, the All-cause Survival endpoint combined both groups into one analysis population. Subjects contributed data according to the follow-up period during they received VNS therapy (Implant through 18 months for Therapy subjects, 6 through 18 months for Control subjects). Control patients who exited the study in the first 6 months, or who did not have a 6 month visit, were excluded.
Time frame: 18-months
LVEF, Left Ventricular Ejection Fraction
LVEF, left ventricular ejection fraction.
Time frame: LVEF at Baseline and at 6-months after Baseline
Exercise Capacity, Peak VO2
Assessment of functional capacity (e.g., peak VO2) as measures related to patient heart failure status.
Time frame: Measurements at Baseline and at 6-months after Baseline
LVESV, Left Ventricular End Systolic Volume
Measurements of LVESV, left ventricular end systolic volume at Baseline and 6 months after Baseline in the Control Arm and in the Therapy Arm
Time frame: At Baseline and at 6-months after Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Blood draw before implant and 6 months after implant at the end of the randomization phase.
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
Napoli, Italy
...and 11 more locations