Clinical trial NCT05009914: A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.
Official title: Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Denervation
Postoperative Atrial Fibrillation
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2021-08-18
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of POAF during hospital.
timeFrame: 6 days after surgery.
Secondary outcomes:
measure: Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.
timeFrame: Postoperative hospitalization, an average of 8 days.
measure: Incidence of transferring to on-pump CABG caused by cardiac denervation.
timeFrame: Intraoperatively.
measure: Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.
timeFrame: Postoperative hospitalization, an average of 8 days.
measure: Incidence of pericarial effusion within 30 days after discharged.
timeFrame: within 30 days after discharged.
measure: Incidence of arrhythmia exclude of AF within 30 days after discharged.
timeFrame: within 30 days after discharged.
measure: Postoperative length of hospitalization.
timeFrame: Postoperative hospitalization, an average of 8 days.
measure: All cost after surgery.
timeFrame: Postoperative hospitalization, an average of 8 days.
measure: MACCE
timeFrame: within 30 days after discharged.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Wei Feng, MD PhD
role: STUDY_CHAIR
References: