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

Postoperative Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05009914
• Other study ID #: NCRC2020003
• Status: Completed
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: January 30, 2024

Study information

• Verified date: May 2024
• Source: China National Center for Cardiovascular Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: January 30, 2024
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Postoperative Atrial Fibrillation

Intervention

Procedure:
• cardiac denervation
Excision of Marshall ligament and Waterstone fat pad during CABG.

Locations

Country	Name	City	State
China	Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of POAF during hospital.	Incidence of postoperative atrial fibrillation after surgery during hospital.	6 days after surgery.
Secondary	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.	Postoperative hospitalization, an average of 8 days.
Secondary	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.	Intraoperatively.
Secondary	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.	Postoperative hospitalization, an average of 8 days.
Secondary	Incidence of pericarial effusion within 30 days after discharged.	The incidence of pericarial effusion within 30 days after discharged.	within 30 days after discharged.
Secondary	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.
Secondary	Postoperative length of hospitalization.	Each participant's oostoperative length of hospitalization.	Postoperative hospitalization, an average of 8 days.
Secondary	All cost after surgery.	All cost associated with treatment after surgery during in-hospital time.	Postoperative hospitalization, an average of 8 days.
Secondary	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.	within 30 days after discharged.