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Completed

NCT Number: NCT05009914

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

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.

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Key information

Conditions

Cardiac Denervation Postoperative Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

cardiac denervation

Procedure

Excision of Marshall ligament and Waterstone fat pad during CABG.

Primary outcomes

  1. Incidence of POAF during hospital.

    Time frame: 6 days after surgery.

    Incidence of postoperative atrial fibrillation after surgery during hospital.

Secondary outcomes

  1. Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.

    Time frame: Postoperative hospitalization, an average of 8 days.

    The incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation during in-hospital time.

  2. Incidence of transferring to on-pump CABG caused by cardiac denervation.

    Time frame: Intraoperatively.

    The incidence of transferring to on-pump CABG caused by cardiac denervation during in-hospital time.

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

    Time frame: Postoperative hospitalization, an average of 8 days.

    The incidence of re-operation aiming to stop bleeding caused by cardiac denervation during in-hospital time.

  4. Incidence of pericarial effusion within 30 days after discharged.

    Time frame: within 30 days after discharged.

    The incidence of pericarial effusion within 30 days after discharged.

  5. Incidence of arrhythmia exclude of AF within 30 days after discharged.

    Time frame: within 30 days after discharged.

    The incidence of arrhythmia exclude of AF within 30 days after discharged.

  6. Postoperative length of hospitalization.

    Time frame: Postoperative hospitalization, an average of 8 days.

    Each participant's oostoperative length of hospitalization.

  7. All cost after surgery.

    Time frame: Postoperative hospitalization, an average of 8 days.

    All cost associated with treatment after surgery during in-hospital time.

  8. MACCE

    Time frame: within 30 days after discharged.

    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.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 18, 2021
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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