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

NCT ID: NCT05009914

Last Updated: 2024-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 430 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2024-01-30

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.

Conditions

Cardiac Denervation; Postoperative Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

cardiac denervation group

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.

Group Type: EXPERIMENTAL

cardiac denervation

Intervention Type: PROCEDURE

Excision of Marshall ligament and Waterstone fat pad during CABG.

controlled group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

cardiac denervation

Excision of Marshall ligament and Waterstone fat pad during CABG.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Feng, MD PhD

Role: STUDY_CHAIR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, , China

Countries

China

References

Yang Z, Tiemuerniyazi X, Xu F, Wang Y, Sun Y, Yan P, Tian L, Han C, Zhang Y, Pan S, Hu Z, Li X, Zhao W, Feng W. Partial Cardiac Denervation to Prevent Postoperative Atrial Fibrillation After Coronary Artery Bypass Grafting: The pCAD-POAF Randomized Clinical Trial. JAMA Cardiol. 2025 Jan 1;10(1):71-77. doi: 10.1001/jamacardio.2024.4639.

Reference Type: DERIVED

PMID: 39550720 (View on PubMed)

Other Identifiers

NCRC2020003

Identifier Type: -

Identifier Source: org_study_id