Cardiac Denervation in Aortic Arch Replacement

Launched by BEIJING ANZHEN HOSPITAL · Apr 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called cardiac denervation to see if it can help prevent a common heart problem known as atrial fibrillation (AF) in patients undergoing surgery for aortic arch replacement. Atrial fibrillation can happen after this type of surgery, affecting how well the heart beats and increasing the risk of serious complications. The trial aims to find out if performing cardiac denervation at the same time as the aortic surgery can lower the chances of developing AF and improve overall recovery.

To participate in the trial, you need to be an adult diagnosed with either aortic dissection or aortic aneurysm and scheduled for total aortic arch replacement surgery. You must be able to understand and agree to participate in the study. The trial will randomly assign you to one of two groups: one will receive the cardiac denervation procedure along with the surgery, while the other will only have the aortic surgery. Researchers will monitor both groups for signs of new atrial fibrillation from one hour after surgery up to six days later. This study is important because it could lead to better outcomes for patients undergoing aortic arch surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, over 18 years old, of Han nationality;
• • 2. Diagnosed with aortic dissection or aortic aneurysm and having undergone total aortic arch artificial vessel replacement surgery under cardiopulmonary bypass;
• • 3. Capable of fully understanding the content of informed consent for this trial and willing to voluntarily sign a written informed consent form.
• Exclusion Criteria:
• • 1. Patients with severe coagulation dysfunction;
• • 2. Pregnant women;
• • 3. History of previous heart surgery;
• • 4. Concurrent receipt of other heart surgeries (e.g., congenital heart disease repair, coronary artery bypass grafting, valve surgery, etc.);
• • 5. History of atrial fibrillation (defined as an arrhythmia characterized by rapid and irregular electrical activity in the atria);
• • 6. 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;
• • 7. Administration of antiarrhythmic drugs other than beta-blockers within 2 weeks before surgery;
• • 8. Patients with cognitive impairment or inability to care for themselves in daily life;
• • 9. Other populations deemed unsuitable for enrollment by the investigator.