Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction

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).

Inclusion Criteria:Male or female patients aged ≥18 yearsST-elevation myocardial infarction which is treated with a primary percutaneous coronary interventionSigned written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up scheduleExclusion Criteria:A patient will be excluded from the study if one or more of all the following criteria are present:< 3 months after prior ablationPatients on amiodaronePatients with known thyroid issues, on renal-dialysisLife expectancy of < 12 monthsComplex congenital heart diseaseCardiogenic shockWomen who are pregnant (as evidenced by pregnancy test if pre-menopausal)Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardiaSymptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemakerComplete heart block or trifascicular block without an implantable pacemakerRecurrent vasovagal syncopePre-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 listRecurrent 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)