Atrial fibrillation (AF) is one of the most common clinical arrhythmias, particularly after cardiac surgery, where its incidence can reach as high as 10% to 40%, significantly impacting patients' prognosis. AF not only reduces patients' quality of life but also significantly increases the incidence of adverse cardiovascular events and postoperative mortality.
There is a risk of new-onset AF after aortic arch replacement surgery, with approximately 16% of patients experiencing new-onset AF postoperatively. AF affects the normal beating of the heart and normal blood flow, and it increases postoperative mortality for patients. The procedure to be conducted, cardiac denervation, is a strategy to prevent postoperative AF, with the expectation of reducing your risk of postoperative AF and improving your prognosis.
Cardiac denervation is a well-established surgical procedure that has been proven to be simple, feasible, safe, and effective in patients undergoing coronary artery bypass grafting (CABG) surgery, and it can reduce the incidence of AF in these patients. Researching the preventive effect of surgical cardiac denervation on AF after aortic surgery is of great significance for reducing complications after cardiac surgery and improving patients' prognosis.
The objective of this study is to verify the safety and effectiveness of cardiac denervation in patients undergoing aortic arch surgery through a randomized controlled trial.
The study subjects are patients with a definitive diagnosis of aortic dissection or aortic aneurysm who undergo total aortic arch artificial vessel replacement surgery under cardiopulmonary bypass.
The intervention involves randomly dividing patients into an intervention group and a control group. The intervention group undergoes cardiac denervation surgery simultaneously with the aortic arch surgery. The control group only receives the aortic arch surgery.
The study outcome is the incidence of new-onset atrial fibrillation from 1 hour postoperatively to 6 days postoperatively.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, over 18 years old, of Han nationality;
. Diagnosed with aortic dissection or aortic aneurysm and having undergone total aortic arch artificial vessel replacement surgery under cardiopulmonary bypass;
. Capable of fully understanding the content of informed consent for this trial and willing to voluntarily sign a written informed consent form.
Exclusion criteria
. Patients with severe coagulation dysfunction;
. Pregnant women;
. History of previous heart surgery;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
New-onset atrial fibrillation
Timeframe: From 1 hour postoperatively to 6 days postoperatively.
. Concurrent receipt of other heart surgeries (e.g., congenital heart disease repair, coronary artery bypass grafting, valve surgery, etc.);
. History of atrial fibrillation (defined as an arrhythmia characterized by rapid and irregular electrical activity in the atria);
. History of coronary heart disease: including hospitalization due to acute myocardial infarction or unstable angina within the last 6 months; revascularization surgery (PCI or CABG) performed within the last 12 months; planned revascularization surgery (PCI or CABG) within the next 6 months;
. Administration of antiarrhythmic drugs other than beta-blockers within 2 weeks before surgery;
. Patients with cognitive impairment or inability to care for themselves in daily life;