Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 6:40 PM
Study NCT ID:
NCT06927908
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Denervation in Aortic Arch Replacement
Sponsor:
Beijing Anzhen Hospital
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Cardiac Denervation for Reducing the Risk of Atrial Fibrillation After Aortic Arch Replacement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: