A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.
- Conditions
- Cardiac DenervationPostoperative Atrial Fibrillation
- Interventions
- Procedure: cardiac denervation
- Registration Number
- NCT05009914
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- Brief Summary
This is a prospective, random controlled trial(RCT) study. 430 patients undergoing coronary artery bypass grafting were enrolled. Our new way of cardiac denervation, defined as excision of Marshall ligament and Waterstone fat pad, was performed in 215 patients, and the other 215 patients were used as control subjects. All the patients need to equip with electronic monitor to record heart rhythms within 6 days after CABG. The investigators will compare the incidence of postoperative atrial fibrillation between two groups, and follow up 30 days after discharged.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 430
- Patients undergoing simple CABG (on-pump/off-pump) for the first time.
- Patients who signed the informed consent form and willing to undergo cardiac denervation.
- Age < 18；
- Emergent CABG;
- Cardiac surgery history；
- Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery；
- Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP;
- History of AF ;
- Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description cardiac denervation group cardiac denervation In this group, patients undergoing CABG will receive the procedure of our new way of cardiac denervation, excision of Marshall ligament and Waterstone fat pad.
- Primary Outcome Measures
Name Time Method Incidence of POAF during hospital. 6 days after surgery. Incidence of postoperative atrial fibrillation after surgery during hospital.
- Secondary Outcome Measures
Name Time Method Incidence of re-operation aiming to stop bleeding caused by cardiac denervation. Postoperative hospitalization, an average of 8 days. The incidence of re-operation aiming to stop bleeding caused by cardiac denervation during in-hospital time.
Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation. Postoperative hospitalization, an average of 8 days. The incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation during in-hospital time.
Incidence of transferring to on-pump CABG caused by cardiac denervation. Intraoperatively. The incidence of transferring to on-pump CABG caused by cardiac denervation during in-hospital time.
All cost after surgery. Postoperative hospitalization, an average of 8 days. All cost associated with treatment after surgery during in-hospital time.
Incidence of pericarial effusion within 30 days after discharged. within 30 days after discharged. The incidence of pericarial effusion within 30 days after discharged.
Incidence of arrhythmia exclude of AF within 30 days after discharged. within 30 days after discharged. The incidence of arrhythmia exclude of AF within 30 days after discharged.
Postoperative length of hospitalization. Postoperative hospitalization, an average of 8 days. Each participant's oostoperative length of hospitalization.
MACCE within 30 days after discharged. major adverse cardiovascular and cerebrovascular events (MACCE), which was defined as the composite of stroke, myocardial infarction, repeat coronary revascularization and all-cause mortality during the 30-day follow-up.
Trial Locations
- Locations (1)
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
🇨🇳Beijing, China