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Could a pacemaker for the vagus nerve tame heart failure?

NCT ID NCT01385176

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

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.

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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

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