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

National Center for Cardiovascular Diseases

Status: Completed

Conditions: Postoperative Atrial Fibrillation; Cardiac Denervation

Treatments: Procedure: cardiac denervation

Study type: Interventional

Funder types: Other

Identifiers

NCT05009914

NCRC2020003

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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430 participants in 2 patient groups

cardiac denervation group

Experimental group

Description:

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.

Treatment:

Procedure: cardiac denervation

controlled group

No Intervention group

Description:

In this group ,patients undergoing CABG will not receive the procedure of cardiac denervation.