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

Primary Purpose

Cardiac Denervation, Postoperative Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
cardiac denervation
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Denervation

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

cardiac denervation group

controlled group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Incidence of POAF during hospital.
Incidence of postoperative atrial fibrillation after surgery during hospital.

Secondary Outcome Measures

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.
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.
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.
Incidence of pericarial effusion within 30 days after discharged.
The incidence of pericarial effusion within 30 days after discharged.
Incidence of arrhythmia exclude of AF within 30 days after discharged.
The incidence of arrhythmia exclude of AF within 30 days after discharged.
Length of in-hospital time.
The length of patient's in-hospital time.
All cost during in-hospital time.
All cost associated with treatment during in-hospital time.
All cost after surgery.
All cost associated with treatment after surgery during in-hospital time.

Full Information

First Posted
June 29, 2021
Last Updated
August 10, 2022
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT05009914
Brief Title
A New Way of Cardiac Denervation to Reduce the Incidence of AF After CABG.
Official Title
Assessing a New Way of Cardiac Denervation to Reduce the Incidence of Atrial Fibrillation After Coronary Artery Bypass Grafting.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
September 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Center for Cardiovascular Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Denervation, Postoperative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cardiac denervation group
Arm Type
Experimental
Arm Description
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.
Arm Title
controlled group
Arm Type
No Intervention
Arm Description
In this group ,patients undergoing CABG will not receive the procedure of cardiac denervation.
Intervention Type
Procedure
Intervention Name(s)
cardiac denervation
Intervention Description
Excision of Marshall ligament and Waterstone fat pad during CABG.
Primary Outcome Measure Information:
Title
Incidence of POAF during hospital.
Description
Incidence of postoperative atrial fibrillation after surgery during hospital.
Time Frame
6 days after surgery.
Secondary Outcome Measure Information:
Title
Incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation.
Description
The incidence of massive haemorrhage needing blood transfusion caused by cardiac denervation during in-hospital time.
Time Frame
In-hospital time, an average of 2 weeks.
Title
Incidence of transferring to on-pump CABG caused by cardiac denervation.
Description
The incidence of transferring to on-pump CABG caused by cardiac denervation during in-hospital time.
Time Frame
In-hospital time, an average of 2 weeks.
Title
Incidence of re-operation aiming to stop bleeding caused by cardiac denervation.
Description
The incidence of re-operation aiming to stop bleeding caused by cardiac denervation during in-hospital time.
Time Frame
In-hospital time, an average of 2 weeks.
Title
Incidence of pericarial effusion within 30 days after discharged.
Description
The incidence of pericarial effusion within 30 days after discharged.
Time Frame
within 30 days after discharged.
Title
Incidence of arrhythmia exclude of AF within 30 days after discharged.
Description
The incidence of arrhythmia exclude of AF within 30 days after discharged.
Time Frame
within 30 days after discharged.
Title
Length of in-hospital time.
Description
The length of patient's in-hospital time.
Time Frame
In-hospital time, an average of 2 weeks.
Title
All cost during in-hospital time.
Description
All cost associated with treatment during in-hospital time.
Time Frame
In-hospital time, an average of 2 weeks.
Title
All cost after surgery.
Description
All cost associated with treatment after surgery during in-hospital time.
Time Frame
In-hospital time after surgery,an average of 10 days.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ZiAng Yang, Bachelor
Phone
19801109287
Email
yzang47@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
YangWu Song, PhD
Phone
18800161699
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Feng, MD PhD
Organizational Affiliation
Chinese Academy of Medical Sciences, Fuwai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Feng, MD PhD
Phone
+86-1380-1018-685
Email
fengwei@fuwai.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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