A Single-Center, Randomized, Open-Label Study of Transcutaneous Regulation for Atrial Prevention in Postoperative Atrial Fibrillation Following OPCAB
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 410
- 主要终点
- Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
研究概览
简要总结
Postoperative atrial fibrillation (POAF) is a common complication after coronary artery bypass surgery and may be associated with prolonged hospitalization and adverse cardiovascular outcomes. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that delivers mild electrical stimulation to the ear and may help regulate autonomic and inflammatory responses.
This randomized controlled trial will evaluate whether perioperative taVNS can reduce the incidence of POAF in adults undergoing elective off-pump coronary artery bypass grafting (OPCAB). Participants will be randomly assigned in a 1:1 ratio to receive either taVNS in addition to standard perioperative care or standard perioperative care alone. The primary outcome is the incidence of new-onset atrial fibrillation within 7 days after surgery. Secondary outcomes will include atrial fibrillation burden, inflammatory markers, heart rate variability, use of antiarrhythmic and anticoagulant medications, safety, length of hospital stay, and major adverse cardiovascular events during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Scheduled to undergo elective off-pump coronary artery bypass grafting (OPCAB) for coronary artery disease with multivessel coronary artery disease.
- •Sinus rhythm on the preoperative baseline electrocardiogram, with no history of atrial fibrillation or other clinically significant arrhythmias.
- •Able and willing to provide written informed consent and comply with the study intervention and follow-up procedures.
- •Expected postoperative hospital stay of at least 7 days to allow postoperative atrial fibrillation monitoring.
排除标准
- •History of atrial fibrillation or other arrhythmias requiring antiarrhythmic therapy.
- •Emergency OPCAB surgery or intraoperative conversion to on-pump coronary artery bypass grafting.
- •Concomitant cardiac surgery, such as valve surgery, or hybrid cardiac procedures.
- •Vagus nerve-related disorders, epilepsy, active ear infection, or implanted electrical devices such as a pacemaker or implantable cardioverter-defibrillator.
- •Severe comorbidities, including severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²), active malignancy, current immunosuppressive therapy, or chronic inflammatory disease.
- •Inability to tolerate auricular stimulation, including significant skin allergy or intolerance, or anticipated poor adherence to the study procedures.
- •Expected survival of less than 12 months or inability to complete follow-up.
研究组 & 干预措施
taVNS Plus Standard Care
Participants assigned to this arm will receive perioperative transcutaneous auricular vagus nerve stimulation (taVNS) in addition to standard perioperative care for off-pump coronary artery bypass grafting.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Standard Care
Participants assigned to this arm will receive standard perioperative care for off-pump coronary artery bypass grafting without taVNS.
结局指标
主要结局
Incidence of New-Onset Postoperative Atrial Fibrillation Within 7 Days After OPCAB
时间窗: From the end of surgery through postoperative day 7
The proportion of participants who develop new-onset postoperative atrial fibrillation (POAF) after off-pump coronary artery bypass grafting. POAF is defined as an episode of atrial fibrillation lasting at least 30 seconds, detected by continuous electrocardiographic monitoring, Holter monitoring, or telemetry. Events will be adjudicated by outcome assessors blinded to treatment allocation.
次要结局
- Duration of Postoperative Atrial Fibrillation(From the end of surgery through postoperative day 7)
- Change in Circulating Inflammatory Markers(Baseline and postoperative 24, 72 and 120 hours)
- Heart Rate Variability(From the end of surgery through postoperative day 7)
- Use of Antiarrhythmic Medication for Postoperative Atrial Fibrillation(Through postoperative day 7)
- Initiation of Anticoagulation for Postoperative Atrial Fibrillation(Through postoperative day 7)