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Could a pacemaker for the vagus nerve tame heart failure?

NCT ID NCT01385176

Disease control Sponsor: Boston Scientific Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests a device that electrically stimulates the vagus nerve to help manage heart failure. About 118 patients with moderate-to-severe heart failure received the implant. The goal is to see if this stimulation can improve heart function and exercise capacity over six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vagus nerve stimulation device
What this could lead to
If successful, this could offer a new device-based option to help control heart failure and improve quality of life.
What could go wrong
This is an early feasibility study with only 118 participants. The device requires surgery, and it is unclear if the benefits will outweigh risks or be confirmed in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

118 people

The number who actually took part.

Started

Sep 2011

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

congestive heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Congestive heart failure Heart failure

Contacts and locations

Locations

  • A. O. Dei Colli - Monaldi

    Naples, 80131, Italy

  • Azienda Ospedaliera Niguarda Cà Granda

    Milan, 20162, Italy

  • CHRU de Lille - Hôpital Cardiologique

    Lille, 59037, France

  • Catharina Ziekenhuis Eindhoven

    Eindhoven, 5623EJ, Netherlands

  • Centre d'Investigation Clinique Pierre Drouin, CHU de Nancy

    Vandœuvre-lès-Nancy, Nancy, 54500, France

  • 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

  • Immanuel Klinikum Bernau Herzzentrum Brandenburg

    Bernau bei Berlin, Brandenburg, 16321, Germany

  • 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

  • Liverpool Heart and Chest Hospital, NHS Foundation Trust

    Liverpool, England, L14 3PD, United Kingdom

  • Nemocnice Na Homolce

    Prague, 15030, Czechia

  • Policlinico San Matteo

    Pavia, 27100, Italy

  • The Heart Hospital, University College London Hospitals, NHS Foundation Trust

    London, England, W1G 8PH, United Kingdom

  • UCL Bruxelles

    Brussels, 1200, Belgium

  • UMC Utrecht

    Utrecht, 3584CX, Netherlands

  • University Hospitals Bristol, NHS Foundation Trust

    Bristol, England, BS2 8HW, United Kingdom

  • Universitäres Herzzentrum GmbH, Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 04103, Germany

  • Universitätsmedizin Göttingen

    Göttingen, 37075, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.