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: Not yet recruiting

Administrative data

• NCT number: NCT05009914
• Other study ID #: NCRC2020003
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: July 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: ZiAng Yang, Bachelor
• Phone: 19801109287
• Email: yzang47[@]163.com
• 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: Not yet recruiting
• Enrollment: 430
• Est. completion date: September 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

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.	In-hospital time, an average of 2 weeks.
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.	In-hospital time, an average of 2 weeks.
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.	In-hospital time, an average of 2 weeks.
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	Length of in-hospital time.	The length of patient's in-hospital time.	In-hospital time, an average of 2 weeks.
Secondary	All cost during in-hospital time.	All cost associated with treatment during in-hospital time.	In-hospital time, an average of 2 weeks.
Secondary	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.