Rationale and design of the VAST-AF trial: A randomized controlled, blinded, clinical trial to evaluate transcutaneous vagal nerve stimulation for the prevention of persistent atrial fibrillation recurrence

Abstract

Background: Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia and is linked to significant symptoms and an elevated risk of heart failure, thromboembolism and disabling stroke. Not only do patients suffer from AF and the concomitant complications, but it is a great economic burden for healthcare systems all over the world. Despite remarkable progress in the field of AF, the basic mechanisms of AF development remain unresolved. Data suggests that the (cardiac) autonomous nervous system (ANS) plays a significant role in AF. Recent studies have shown that stimulating the ANS could have a beneficial effect on paroxysmal and postoperative AF. Consequently, this therapy could provide another viable target for treating persistent AF, as well.

Methods: The VAST-AF trial is a prospective, double-blinded, randomized, and sham-controlled clinical trial. One hundred and twenty patients diagnosed with persistent AF and cardioversion in sinus rhythm (SR) will be randomly assigned to either transcutaneous vagal nerve stimulation (tVNS) or sham treatment in a 1:1 ratio. The primary objective of this study is to examine whether a daily tVNS reduces the recurrence rate of AF. Secondary endpoints include quality of life, time to first AF recurrence and ECG parameters of the ANS. Follow-up is scheduled at 30 days, 3 and 6 months. After 3 months, stimulation is withdrawn, and patients evaluated regarding a still detectable effect of tVNS.

Conclusion: The VAST-AF trial represents the first randomized and sham-controlled study to investigate the potential benefits of transcutaneous vagal nerve stimulation on the recurrence of atrial fibrillation. Patients with persistent atrial fibrillation and successful electrical cardioversion will be assessed. A decrease in the rate of recurrence and consecutive hospitalizations could decidedly enhance the quality of life of patients and decrease healthcare expenses. Nevertheless, it does not compete with treatments such as catheter ablation, but rather serves as an additional tool in the armamentarium of the electrophysiologist.