Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction (EARLY-VAGUS)
Myocardial Infarction, Tachyarrhythmia
About this trial
This is an interventional prevention trial for Myocardial Infarction focused on measuring transcutaneous vagal nerve stimulation
Eligibility Criteria
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)
Sites / Locations
- Heart Rhythm Institute, University of Oklahoma Health Sciences Center
- First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
- Athens Heart Center Amarousion
- Biomedical Engineering, Khalifa University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active Transcutaneous Vagal Nerve Stimulation
Sham Transcutaneous Vagal Nerve Stimulation