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Clinical Trials in the UK / NCT01385176
Active, not recruiting Not applicable

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

NCT01385176 · tracked via the Priya Life Science UK tracker
Sponsor
Boston Scientific Corporation
Phase
Not applicable
Started
2011-09-21
Last updated
2026-08-14

Condition(s) studied

Heart FailureCongestive Heart Failure

Investigational drug(s) / intervention(s)

Implant of investigational device systemTitration during the randomization phaseTitration after the randomization phaseBlood Draw

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Age 18 or above, and of legal age to give informed consent specific to national laws * Willing and capable of providing informed consent * Capable of participating in all testing associated with this clinical investigation * Stable symptomatic heart failure NYHA class II-III * Left ventricular (LV) ejection fraction equal or smaller than 35 % * Left ventricular end diastolic diameter (LVEDD) of 5.5 cm or greater * Prescribed to optimal pharmacologic therapy Exclusion Criteria: * QRS larger than 130 ms * Patients who have been hospitalized for heart failure and who required the use of HF IV therapy within 30 days before enrollment * Patients unable to tolerate anesthesia required for implant * Patients with unstable angina, myocardial infarction, PTCA, coronary artery bypass graft, cerebral vascular accident, or transient ischemic attack within previous 90 days before enrollment * Patients whose primary cause of heart failure is mitral or aortic valve disease, with a severe classification * Patients with persistent or permanent atrial fibrillation within 90 days prior to enrollment * Pacemaker indicated patients * Patients whose heart failure is due to congenital heart disease * Patients who have started treatment for sleep apnea or sleep disordered breathing with therapies to maintain airway patency (e.g., CPAP, Bi-PAP,APAP) with or without oxygen supplementation within the previous 6 months prior to enrollment * Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) * Patients with documented chronic obstructive lung disease * Patients on or indicated for renal dialysis * Type 1 diabetic patients * Type 2 diabetic patients that have been treated with insulin for more than 5 years prior to enrollment * Patients with a life expectancy of less than 12 months per physician judgment * Patients involved in any concurrent clinical investigation * Women of childbearing potential who are or might be pregnant at the time of the study or breastfeeding * Patients with a prior cardiac transplant or expecting a heart transplant operation within the next 12 months * Patients with a prior vagotomy * Patients with prior or existing vagal nerve stimulation treatment * Patients implanted with any active implantable medical device other than a left sided single or dual chamber implantable cardioverter defibrillator (ICD) with bipolar sensing, or a left sided CRT device with each sensing channel programmed to either bipolar sensing or no sensing. All CRT patients must have had CRT for at least 1 year prior to enrollment. The total number of CRT patients will not exceed 30 * Patients with locally implanted semi-/permanent devices such as vascular catheters, etc. that would interfere with the NECTAR-HF study system * Patients with previously implanted devices on the right side that became infected before removal * Patients with previous neck surgery and resultant scar formation that interferes with the ability to implant the study system on the right side of the neck (Thyroid/parathyroid, carotid artery etc) * Patients with known recurrent nerve paralysis * Patients who have undergone radiotherapy for thyroid disease/cancer * Patients who have existing or prior tracheotomy * Patients with severe vertebral cervical disease and limited mobility in the neck; includes those that frequently wear a brace * Patients with carotid murmur/vascular bruit/carotid artery lesion * Patients with known/suspected vascular malformation in carotid/vertebral circulatory bed * Patients who are likely to need an MRI of the neck area because of previous medical conditions

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
UCL Bruxelles Brussels Belgium
Nemocnice Na Homolce Prague Czechia
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy Vandœuvre-lès-Nancy Nancy
CHRU de Lille - Hôpital Cardiologique Lille France
Immanuel Klinikum Bernau Herzzentrum Brandenburg Bernau bei Berlin Brandenburg
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
Hospital Clinic de Barcelona Barcelona Spain
Hospital Doce de Octubre Madrid Spain
University Hospitals Bristol, NHS Foundation Trust Bristol England
Liverpool Heart and Chest Hospital, NHS Foundation Trust Liverpool England
The Heart Hospital, University College London Hospitals, NHS Foundation Trust London England
Imperial College Healthcare NHS Trust, St. Mary's Hospital London England
King's College Hospital NHS Foundation Trust London United Kingdom

More Boston Scientific Corporation trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01385176 on ClinicalTrials.gov ↗ ← All trials in the UK