Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)
NCT ID: NCT01385176
Last Updated: 2025-12-04
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
118 participants
INTERVENTIONAL
2011-09-21
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Therapy
Implant of investigational device system for vagus nerve stimulation. Patients were randomized in a 2 : 1 ratio to receive therapy (VNS ON) or control (VNS OFF) for a 6-month period.
The experimental arm was receiving vagus nerve stimulation during the first 6 months after implant.
Titration during the randomization phase with delivery of highest tolerable by patient stimulation current.
Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current.
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.
Control
Implant of investigational device system for vagus nerve stimulation. Control group was implanted with study system like the experimental arm, but was not receiving experimental vagus nerve stimulation therapy during the first 6 months after implant. 6-month after implant a cross-over took place and the control arm also started to receive experimental vagus nerve stimulation.
Blood Draw before implant and 6 months after implant. Titration after the randomization phase with adjustments of the chronically highest tolearble by patient current.
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 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Faiez Zannad, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy
Locations
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UMC Utrecht
Utrecht, , Netherlands
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
Napoli, , Italy
Policlinico San Matteo
Pavia, , Italy
Catharina Ziekenhuis Eindhoven
Eindhoven, , 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
Countries
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References
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De Ferrari GM, Tuinenburg AE, Ruble S, Brugada J, Klein H, Butter C, Wright DJ, Schubert B, Solomon S, Meyer S, Stein K, Ramuzat A, Zannad F. Rationale and study design of the NEuroCardiac TherApy foR Heart Failure Study: NECTAR-HF. Eur J Heart Fail. 2014 Jun;16(6):692-9. doi: 10.1002/ejhf.80. Epub 2014 May 20.
Zannad F, De Ferrari GM, Tuinenburg AE, Wright D, Brugada J, Butter C, Klein H, Stolen C, Meyer S, Stein KM, Ramuzat A, Schubert B, Daum D, Neuzil P, Botman C, Castel MA, D'Onofrio A, Solomon SD, Wold N, Ruble SB. Chronic vagal stimulation for the treatment of low ejection fraction heart failure: results of the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) randomized controlled trial. Eur Heart J. 2015 Feb 14;36(7):425-33. doi: 10.1093/eurheartj/ehu345. Epub 2014 Aug 31.
De Ferrari GM, Stolen C, Tuinenburg AE, Wright DJ, Brugada J, Butter C, Klein H, Neuzil P, Botman C, Castel MA, D'Onofrio A, de Borst GJ, Solomon S, Stein KM, Schubert B, Stalsberg K, Wold N, Ruble S, Zannad F. Long-term vagal stimulation for heart failure: Eighteen month results from the NEural Cardiac TherApy foR Heart Failure (NECTAR-HF) trial. Int J Cardiol. 2017 Oct 1;244:229-234. doi: 10.1016/j.ijcard.2017.06.036. Epub 2017 Jun 10.
Other Identifiers
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NECTAR-1109
Identifier Type: -
Identifier Source: org_study_id
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