Cardiac Denervation, Postoperative Atrial Fibrillation
Conditions
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.
Interventions
PROCEDUREcardiac denervation
Excision of Marshall ligament and Waterstone fat pad during CABG.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing simple CABG (on-pump/off-pump) for the first time. 2. Patients who signed the informed consent form and willing to undergo cardiac denervation.
Exclusion criteria
1. Age \< 18； 2. Emergent CABG; 3. Cardiac surgery history； 4. Receiving other cardiac surgery except of CABG at the same time, such as Morrow、valvular surgery、ventricular aneurysm surgery、congenital heart diseases surgery； 5. Requiring mechanical or pharmacological therapy for hemodynamic support before CABG, such as ECMO or IABP; 6. History of AF ; 7. Taking antiarrhythmic agents except of beta-blockers last 2 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of POAF during hospital. | 6 days after surgery. | Incidence of postoperative atrial fibrillation after surgery during hospital. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 pericarial effusion within 30 days after discharged. | within 30 days after discharged. | The incidence of pericarial effusion within 30 days after discharged. |
| 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. |
| Postoperative length of hospitalization. | Postoperative hospitalization, an average of 8 days. | Each participant's oostoperative length of hospitalization. |
| All cost after surgery. | Postoperative hospitalization, an average of 8 days. | All cost associated with treatment after surgery during in-hospital time. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed