A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.

China National Center for Cardiovascular Diseases430 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

430

Conditions

Cardiac Denervation Postoperative Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of POAF during hospital.

Incidence of postoperative atrial fibrillation after surgery during hospital.

Time frame: 6 days after surgery.

Secondary Outcomes

Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.

The incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation during in-hospital time.

Time frame: Postoperative hospitalization, an average of 8 days.

Incidence of transferring to on-pump CABG caused by cardiac denervation.

The incidence of transferring to on-pump CABG caused by cardiac denervation during in-hospital time.

Time frame: Intraoperatively.

Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.

The incidence of re-operation aiming to stop bleeding caused by cardiac denervation during in-hospital time.

Time frame: Postoperative hospitalization, an average of 8 days.

Incidence of pericarial effusion within 30 days after discharged.

The incidence of pericarial effusion within 30 days after discharged.

Time frame: within 30 days after discharged.

Incidence of arrhythmia exclude of AF within 30 days after discharged.

The incidence of arrhythmia exclude of AF within 30 days after discharged.

Time frame: within 30 days after discharged.

Postoperative length of hospitalization.

Each participant's oostoperative length of hospitalization.

Time frame: Postoperative hospitalization, an average of 8 days.

All cost after surgery.

All cost associated with treatment after surgery during in-hospital time.

Time frame: Postoperative hospitalization, an average of 8 days.

MACCE

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.

Time frame: within 30 days after discharged.

A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes