Key result
New RCT protocol tests TLL-VNS versus sham for preventing postoperative atrial fibrillation.
Why the study?
Postoperative AF occurs in up to 44% of cardiac surgeries, and the efficacy of TLL-VNS for preventing AF after cardiac valve surgery with CPB had not been evaluated in a randomized trial.
Does transcutaneous low-level vagus nerve stimulation prevent postoperative atrial fibrillation in patients undergoing elective cardiac valve surgery with cardiopulmonary bypass?
RCT (n=140)
Double-blind
Computer-generated randomization sequence with a block size of four
No
Does transcutaneous low-level vagus nerve stimulation prevent postoperative atrial fibrillation in patients undergoing elective cardiac valve surgery with cardiopulmonary bypass?
This trial protocol outlines a randomized, sham-controlled study to evaluate the efficacy of transcutaneous low-level vagus nerve stimulation for preventing postoperative atrial fibrillation in patients undergoing cardiac valve surgery.
Answers are grounded in this paper and cite their sources.
This sham-controlled RCT will test TLL-VNS efficacy for post-valve surgery AF; results may extend noninvasive neuromodulation evidence.
Atrial fibrillation (AF) is one of the most common complications following cardiac surgery, with reported incidence rates reaching up to 44%. Transcutaneous low-level vagus nerve stimulation (TLL-VNS) has shown potential in reducing the risk of postoperative AF by modulating autonomic nervous system activity, suppressing inflammation, and regulating atrial ganglionic function. The Vagus-Heart Trial is a prospective, randomized, double-blind, sham-controlled study designed to evaluate the efficacy of TLL-VNS in preventing postoperative AF. A total of 140 patients undergoing elective cardiac valve surgery with cardiopulmonary bypass (CPB) are randomly assigned to receive either active TLL-VNS or sham stimulation. The primary endpoint is the incidence of AF within the first week after surgery. Secondary endpoints include the duration of AF within the first week after surgery, surgical parameters, vital signs, inflammatory markers, renal function, surgical prognosis, and stress response biomarkers. This trial is the first large-scale, randomized, sham-controlled study to evaluate TLL-VNS for the prevention of postoperative AF in patients undergoing cardiac valve surgery with CPB. If proven effective, TLL-VNS could represent a novel, non-invasive, and cost-effective strategy to enhance postoperative recovery and reduce the burden of AF in this high-risk population. Chictr.org.cn Identifer: ChiCTR2400080750. Registered on 6 February 2024.
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Bian et al. (2026) conducted an RCT in Postoperative atrial fibrillation (n=140). Transcutaneous low-level vagus nerve stimulation (TLL-VNS) vs. Sham stimulation was evaluated on Incidence of atrial fibrillation within the first week after surgery. This study is a protocol for a randomized, double-blind, sham-controlled trial designed to evaluate the efficacy of transcutaneous low-level vagus nerve stimulation in preventing postoperative atrial fibrillation.
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