Low Level Transcutaneous Electrical Vagus Nerve Stimulation To Suppress Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Incidence of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay.
研究概览
简要总结
The current study will evaluate the potential of stimulating the R.auricularis of the vagus nerve located at the Fossa triangularis to ameliorate or suppress AF in the study Population!
详细描述
Scientific Background Nearly 30% of patients undergoing coronary artery bypass grafting (CABG), 40% of patients undergoing valvular heart surgery and over 50% of patients with combined coronary and valvular procedures develop atrial fibrillation (AF).
Postoperative AF occurs mostly due to conditions like chronic kidney diseases, emergency surgery, age >75 years, cardiopulmonary bypass time >180 min and due to lacking postoperative application of aldosterone- and beta-blockers.
An overview of pre- intra- and postoperative risks for AF is listed in
Table 1: Pre-, intra-, postoperative risks for AF.
Preoperative High age Male gender Previous cardiac surgery Valvular heart disease Chronic lung disease Chronic renal failure Leſt atrium enlargement Leſt ventricular hypertrophy Withdrawal of beta-blocker medication History of AF Hypertension Obesity Diabetes Metabolic Syndrome
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De-novo postoperative AF
- •CABG or aortic valve replacement
- •Age of 18-80 years
- •Willing and able to understand, sign and date the informed consent form that has been approved by the institutional review board
排除标准
- •Pacemaker or ICD
- •Impaired EF < 30%
- •Patients with acute myocardial infarction within the past 14 days
- •Pregnant or lactating patients
- •Any condition that, in the judgement of the investigator, would place the patient at undue risk
- •Any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study
- •Treatment and/or an uncompleted follow-up treatment of any investigational therapy within 6 months before procedure and intent to participate in any other investigational drug or cell therapy study during the follow-up period of this study
- •Active participation in other Research therapy for cardiovascular repair/regeneration
结局指标
主要结局
Incidence of Atrial Fibrillation events in routine ECG and continous HOLTER ECG for the length of the hospital stay.
时间窗: 07-14 days post operative
Patients are randomized to a treatment or a sham group. The corresponding device is prepared by a third person according to the double-blind setting for the surgeon. The DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed.
次要结局
- Measurement of postoperative inflammation markes, using plasma values of CRP, TNF-alpha, IL-6, and IL-10(07-14 days post operative)
研究者
Alfred A Kocher, MD
Univ. Prof. Dr.
Medical University of Vienna