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NCT05789147Completed

Transcutaneous Vagus Nerve Stimulation in Heart Failure

EffecTs of tRanscutaneous vAgus Nerve Stimulation in Heart Failure Patients With Moderately rEduced or preseRved Left Ventricular Function

Source: ClinicalTrials.gov · Last updated 30 Jan 2025

Brief summary (registry, in English)

Several studies have shown that alterations in autonomic nervous system function are implicated in the onset and progression of numerous cardiovascular diseases. Direct stimulation of the vagus nerve by means of a sleeve placed around the vagus nerve represents one of the methodologies proposed in the field of neuromodulation. This study, which is proposed as a pilot study for further application of the method in subjects with cardiovascular disease aims to verify and consolidate evidence on cardiovascular autonomic effects in patients with heart failure. Vagal stimulation will be achieved noninvasively by applying an external stimulator to the auricular site.

Status (registry)
Completed
Study type
Interventional
Enrollment
29 (actual)
First submitted
28 Feb 2023
Start date
15 Jun 2020
Primary completion date
30 Sept 2024
Lead sponsor
Istituti Clinici Scientifici Maugeri SpA
NCT number
NCT05789147

What you commit to

  • Study type: Interventional
  • Participants enrolled: 29
  • From 15 Jun 2020 to the primary completion date, 30 Sept 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with implanted cardiac device (ICD, CRT),
  • Patients with recent (\< 3 months) cardiac surgery,
  • Patients with recent (\< 3 months) myocardial infarction,
  • Patients with an indication for cardiac surgery within the next 6 months.

Other

  • Patients with recent (\< 3 months) revascularization

Who the study is looking for

  • Heart failure patients with moderately reduced or preserved ejection fraction
  • Sinus rhythm
  • New York Heart Association (NYHA) Class II-III

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Istituti Clinici Scientifici Maugeri IRCCS
Coordinator of this site? Confirm its status
PaviaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.