NCT06927908

Cardiac Denervation in Aortic Arch Replacement

Randomized Controlled Trial of Cardiac Denervation for Reducing the Risk of Atrial Fibrillation After Aortic Arch Replacement

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 570 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation (AF)
• Aortic Arch Replacement

Interventions

Type	Name	Description
PROCEDURE	Partial Cardiac Denervation	Expose the ligament of Marshall (LOM) between the left atrial appendage and left pulmonary veins, and transect it using an electrocautery knife. Expose the fatty pad along the Waterston groove between the right pulmonary veins and the right atrium, and completely resect it down to the myocardial surface, extending the superior margin beyond the ostium of the right superior pulmonary vein and the inferior margin to the inferior vena cava.

Timeline

• Start date: 2025-04-22
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-04-15
• Last updated: 2025-04-15