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

Study Overview
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Brief Summary
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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.

Official Title
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Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.

Conditions
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Cardiac Denervation, Postoperative Atrial Fibrillation

Intervention / Treatment
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* Procedure: cardiac denervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cardiac denervation group<br>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. | Procedure: cardiac denervation<br>* Excision of Marshall ligament and Waterstone fat pad during CABG.<br>|
| No Intervention: controlled group<br>In this group ,patients undergoing CABG will not receive the procedure of cardiac denervation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of POAF during hospital. | Incidence of postoperative atrial fibrillation after surgery during hospital. | 6 days after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | In-hospital time, an average of 2 weeks. | 
| 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. | In-hospital time, an average of 2 weeks. | 
| 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. | In-hospital time, an average of 2 weeks. | 
| Incidence of pericarial effusion within 30 days after discharged. | The incidence of pericarial effusion within 30 days after discharged. | 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. | within 30 days after discharged. | 
| Length of in-hospital time. | The length of patient's in-hospital time. | In-hospital time, an average of 2 weeks. | 
| All cost during in-hospital time. | All cost associated with treatment during in-hospital time. | In-hospital time, an average of 2 weeks. | 
| All cost after surgery. | All cost associated with treatment after surgery during in-hospital time. | In-hospital time after surgery,an average of 10 days. |