Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction (EARLY-VAGUS)

Hippocration General Hospital

Status

Not yet enrolling

Conditions

Myocardial Infarction

Tachyarrhythmia

Treatments

Device: Parasym device (sham, current (mA) = 0)

Device: Parasym device (active, current (mA) < discomfort threshold)

Study type

Interventional

Funder types

Other

Identifiers

NCT05750108

EARLY-VAGUS

Details and patient eligibility

About

Among patients early following ST-segment (ST) elevation myocardial infarction, transcutaneous vagus nerve stimulation is associated with a reduce of the burden of premature ventricular contractions in the first 40 days post-myocardial infarction (MI).

The above hypothesis will be tested with a randomized, prospective, parallel, single-blind clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for June 2023) to the time of study's termination date (December 2024). Patient enrollment is planned to take place at two major centers in Greece. The researchers will obtain approval by the institutional review board (IRB).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients aged ≥18 years
ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention
Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule

Exclusion criteria

A patient will be excluded from the study if one or more of all the following criteria are present:

< 3 months after prior ablation
Patients on amiodarone
Patients with known thyroid issues, on renal-dialysis
Life expectancy of < 12 months
Complex congenital heart disease
Cardiogenic shock
Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker
Complete heart block or trifascicular block without an implantable pacemaker
Recurrent vasovagal syncope
Pre-existing implantable cardioverter-defibrillator (ICD)
Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded))
On the heart transplant list
Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications)
Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)