Active, not recruitingNCT01385176NECTAR-HFUpdated Sep 25, 2026Results posted

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

An interventional study of Implant of investigational device system and Titration during the randomization phase in Heart Failure and Congestive Heart Failure, sponsored by Boston Scientific Corporation. Active, not recruiting at 21 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 118
Allocation: Randomized
Ages: 18 Years and older
Sex: All

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.

Read the detailed description

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.

Conditions studied

Heart Failure
Congestive Heart Failure

Browse trials for

Heart Failure 5,701

Keywords

Heart failure
Congestive heart failure
New York Heart Association Class II-III
Vagal therapy
Vagal nerve stimulation

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 118 is above the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 118 participants (actual)

Study arms

Experimental
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.
Device: Implant of investigational device system · Procedure: Titration during the randomization phase · Procedure: Titration after the randomization phase · Diagnostic Test: Blood Draw
Sham comparator
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.
Device: Implant of investigational device system · Procedure: Titration after the randomization phase · Diagnostic Test: Blood Draw

Interventions

DeviceImplant 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.
ProcedureTitration 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.
ProcedureTitration 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.
Diagnostic testBlood Draw
Blood draw before implant and 6 months after implant at the end of the randomization phase.

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Results

Posted Jan 6, 2020

Limitations and caveats

Inappropriate patient selection may have also contributed to the neutral findings. In the present study, therapy patients experienced side effects (e.g. neck pain, coughing), which limited programming to low stimulation amplitudes.

Participant flow

Enrollment Start: 21-Sep-2011. First implant: 28-Sep-2011.Last Implant: 20-June-2013. 118 patients enrolled, 96 were found to be eligible and were implanted across 24 centres (7 sites with 5-10 implants, 1 site with 13 implants). 95 patients were randomized.

Randomization Phase

Participant flow — Randomization Phase
Milestone	Therapy	Control
Started	63	32
Completed	62	30
Not completed	1	2
Withdrew: Death	1	2

6-18 Month All VNS Active

Participant flow — 6-18 Month All VNS Active
Milestone	Therapy	Control
Started	62	30
Completed	58	27
Not completed	4	3
Withdrew: Death	1	2
Withdrew: Physician decision	0	1
Withdrew: Withdrawal by subject	2	0
Withdrew: Heart transplant	1	0

Outcome measures

PrimaryChange 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
Reported as:: Mean · cm

Change in Left Ventricular End-systolic Dimension (LVESD)
cm	Therapy	Control
Change in Left Ventricular End-systolic Dimension (LVESD)	-0.04 ± 0.25	-0.08 ± 0.32

PrimaryPercentage 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
Reported as:: Number · Percentage of participants surving

Percentage of Surviving Participants
Percentage of participants surving	All Patients in Active VNS Periods
Percentage of Surviving Participants	95 (91 to 99)

SecondaryLVEF, Left Ventricular Ejection Fraction

LVEF, left ventricular ejection fraction.

Time frame:: LVEF at Baseline and at 6-months after Baseline
Reported as:: Mean · % of blood ejected from ventricle

LVEF, Left Ventricular Ejection Fraction
% of blood ejected from ventricle	Therapy	Control
Baseline	30.5 ± 6.0	30.8 ± 4.2
6 months after Baseline	32.7 ± 6.4	32.1 ± 5.6

SecondaryExercise 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
Reported as:: Mean · ml/kg/min

Exercise Capacity, Peak VO2
ml/kg/min	Therapy	Control
Baseline	15.6 ± 3.9	15.2 ± 3.3
6 months after Baseline	15.8 ± 4.4	14.7 ± 3.6

SecondaryLVESV, 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
Reported as:: Mean · ml

LVESV, Left Ventricular End Systolic Volume
ml	Therapy	Control
Baseline	154.7 ± 58.5	164.0 ± 39.2
6 months after Baseline	142.5 ± 57.1	152.1 ± 43.8

Adverse events

Collected over Adverse events information collected during the randomization phase, (6 month) is referred to. During this time period the primary efficicacy endpoint measurements were done and information collected. Only during these initial 6 months there were two goups of patients. After 6 month all patients had received vagus nerve stimulation. An additional Arm/Group ("All Patients - 6 to 18 Months" ) was added to present AEs collected from end of randomization phase until end of safety endpoint period.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Therapy	1/63 (1.6%)	21/63 (33.3%)	32/63 (50.8%)
Control	2/32 (6.3%)	18/32 (56.3%)	15/32 (46.9%)
All Patients - 6 to 18 Months	3/92 (3.3%)	44/92 (47.8%)	66/92 (71.7%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	Therapy	Control	All Patients - 6 to 18 Months
Other Non Cardiocascular, anticipatedGeneral disorders	7/63	7/32	22/92
HF hospitalization, anticipatedCardiac disorders	7/63	5/32	18/92
Cardiovascular - Non Heart Failure, anticipatedCardiac disorders	7/63	5/32	16/92
Investigational device system related, anticipatedProduct Issues	9/63	4/32	2/92
Pulmonary Serious Adverse Events, anticipatedRespiratory, thoracic and mediastinal disorders	0/63	3/32	5/92
Genitourinary, anticipatedRenal and urinary disorders	1/63	2/32	1/92
Death, anticipatedCardiac disorders	1/63	2/32	3/92
Investigational device system related, unanticipatedProduct Issues	0/63	0/32	1/92
Heart Failure Hospitalizations, unanticipatedCardiac disorders	0/63	0/32	0/92
Cardiovascular - Non Heart Failure, unanticipatedCardiac disorders	0/63	0/32	0/92

Most frequent other events

Showing 10 of 12

Most frequent other events
Event	Therapy	Control	All Patients - 6 to 18 Months
Investigational System-Related anticipatedInvestigations	32/63	11/32	25/92
Cardiovascular - not HF related, anticipatedCardiac disorders	21/63	13/32	28/92
Other Non-cardiovascular, anticipatedGeneral disorders	19/63	13/32	34/92
Cardiovascular HF related, anticipatedCardiac disorders	15/63	7/32	21/92
Pulmonary non serious adverse events, anticipatedRespiratory, thoracic and mediastinal disorders	2/63	2/32	8/92
Genitourinary, anticipatedRenal and urinary disorders	1/63	1/32	3/92
Cardiovascular HF related, unanticipatedCardiac disorders	0/63	0/32	0/92
Cardiovascular - not HF related, unanticipatedCardiac disorders	0/63	0/32	0/92
Pulmonary non serious adverse events, unanticipatedRespiratory, thoracic and mediastinal disorders	0/63	0/32	0/92
Genitourinary, unanticipatedRenal and urinary disorders	0/63	0/32	0/92

Baseline characteristics

Patients had a documented LVejection fraction (LVEF) of ≤ 35%, an LV end diastolic dimension (LVEDD) of ≥55 mm, and a New York Heart Association (NYHA) classification of II or III. Patients also had been treated with medical therapy per European heart failure guidelines for at least 30 days prior to enrolment.

Age, Continuous
Age, Continuous(years)	Therapy	Control	Total
Mean	59.8 ± 12.2	59.3 ± 10.1	59.5 ± 11.1

Sex: Female, Male
Sex: Female, Male(Participants)	Therapy	Control	Total
Female	7	6	13
Male	56	26	82

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Therapy	Control	Total
Count of participants	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Therapy	Control	Total
Netherlands	13	6	19
Czech Republic	6	4	10
Belgium	1	1	2
United Kingdom	12	4	16
Italy	5	5	10
France	4	3	7
Germany	12	4	16
Spain	10	5	15

Body mass index
Body mass index(kg/m^2)	Therapy	Control	Total
Mean	28.6 ± 5.9	31.2 ± 5.1	29.9 ± 5.5

Loop diuretics
Loop diuretics(Participants)	Therapy	Control	Total
Count of participants	54	32	86

Statin
Statin(Participants)	Therapy	Control	Total
Count of participants	50	19	69

Study locations

21 sites

UCL Bruxelles
Brussels, 1200, Belgium
Nemocnice Na Homolce
Prague, 15030, Czechia
Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy
Vandœuvre-lès-Nancy, Nancy 54500, France
CHRU de Lille - Hôpital Cardiologique
Lille, 59037, France
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau bei Berlin, Brandenburg 16321, Germany
Universitätsmedizin Göttingen
Göttingen, 37075, Germany
Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
Universitätsklinikum Leipzig
Leipzig, 04103, Germany
Azienda Ospedaliera Niguarda Cà Granda
Milan, 20162, Italy
A. O. Dei Colli - Monaldi
Naples, 80131, Italy
Policlinico San Matteo
Pavia, 27100, Italy
Catharina Ziekenhuis Eindhoven
Eindhoven, 5623EJ, Netherlands
UMC Utrecht
Utrecht, 3584CX, Netherlands
Clínica Universitaria de Navarra, Avenida Pio XII s/n
Pamplona, Navarre 31008, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Doce de Octubre
Madrid, 28041, Spain
University Hospitals Bristol, NHS Foundation Trust
Bristol, England BS2 8HW, United Kingdom
Liverpool Heart and Chest Hospital, NHS Foundation Trust
Liverpool, England L14 3PD, United Kingdom
The Heart Hospital, University College London Hospitals, NHS Foundation Trust
London, England W1G 8PH, United Kingdom
Imperial College Healthcare NHS Trust, St. Mary's Hospital
London, England W2 1NY, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom

References and documents

Publications

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. PubMed 24846173 ↗
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. PubMed 25176942 ↗
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. PubMed 28663046 ↗

Individual participant data

Plan to share: No

Updates

1 registry update since Sep 25, 2026

Minor edits

Nothing that changes what the study is or who can join. Edited: verification date

1 update, last Sep 25, 2026

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Sep 25, 2026
Minor edits only
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01385176
Lead sponsor: Boston Scientific Corporation
Responsible party: Sponsor
First posted: Jun 30, 2011
Start date: Sep 21, 2011
Primary completion: May 2014
Completion: Jun 30, 2027 (estimated)
Results posted: Jan 6, 2020
Last update: Sep 25, 2026

Study contacts

Faiez Zannad, M.D.

principal investigator · Centre d'Investigation Clinique (CIC), Batiment Louis Mathieu, CHU de Nancy

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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