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

China National Center for Cardiovascular Diseases1 site in 1 country430 target enrollmentAugust 15, 2022

ConditionsCardiac Denervation Postoperative Atrial Fibrillation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cardiac Denervation
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 430
Locations: 1
Primary Endpoint: Incidence of POAF during hospital.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 15, 2022

End Date

January 30, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Sponsor

Eligibility Criteria

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

•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.

Outcomes

Primary Outcomes

Incidence of POAF during hospital.

Time Frame: 6 days after surgery.

Incidence of postoperative atrial fibrillation after surgery during hospital.

Secondary Outcomes

Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.(Postoperative hospitalization, an average of 8 days.)
Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.(Postoperative hospitalization, an average of 8 days.)
Incidence of transferring to on-pump CABG caused by cardiac denervation.(Intraoperatively.)
All cost after surgery.(Postoperative hospitalization, an average of 8 days.)
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.(within 30 days after discharged.)
Postoperative length of hospitalization.(Postoperative hospitalization, an average of 8 days.)
MACCE(within 30 days after discharged.)