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

NCT05009914 | Completed

• 1 other identifier: NCRC2020003
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of POAF during hospital.

  Incidence of postoperative atrial fibrillation after surgery during hospital.

  6 days after surgery.

Secondary Outcomes (8)

• 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.

• Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.

  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.

Study Arms (2)

cardiac denervation group

EXPERIMENTAL

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.

Procedure: cardiac denervation

controlled group

NO INTERVENTION

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

Interventions

cardiac denervation PROCEDURE

Excision of Marshall ligament and Waterstone fat pad during CABG.

cardiac denervation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18；
• 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.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

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

Beijing, China

Location

Related Publications (1)

• 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.

  PMID: 39550720 DERIVED

Study Officials

• Wei Feng, MD PhD

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: August 18, 2021
• Study Start: August 15, 2022
• Primary Completion: December 13, 2023
• Study Completion: January 30, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)