NCT06927908Not yet recruiting
Cardiac Denervation in Aortic Arch Replacement
Randomized Controlled Trial of Cardiac Denervation for Reducing the Risk of Atrial Fibrillation After Aortic Arch Replacement
Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 570 (estimated)
- First submitted
- 6 Mar 2025
- Start date
- 22 Apr 2025
- Primary completion date
- 1 Jan 2027
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT06927908
What you commit to
- Study type: Interventional
- Planned participants: 570
- From 22 Apr 2025 to the primary completion date, 1 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of previous heart surgery;
- Concurrent receipt of other heart surgeries (e.g., congenital heart disease repair, coronary artery bypass grafting, valve surgery, etc.);
- Administration of antiarrhythmic drugs other than beta-blockers within 2 weeks before surgery;
Other illness
- 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;
- Patients with cognitive impairment or inability to care for themselves in daily life;
Other
- Patients with severe coagulation dysfunction;
- Pregnant women;
- Other populations deemed unsuitable for enrollment by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.