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Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass

Primary Purpose

Coronary Artery Disease, Stroke, Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Left Atrial Appendage Resection and Marshall Ligament Amputation
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 Coronary Artery Disease focused on measuring off-pump coronary artery bypass, postoperative new-onset atrial fibrillation, left atrial appendage, Marshall ligament

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • isolated first off-pump coronary artery bypass

Exclusion Criteria:

  • Preoperative atrial fibrillation or a history of atrial fibrillation;
  • Concurrent cardiac or non-cardiac surgery
  • Intraoperative convert to bypass bypass surgery
  • Emergency surgery
  • History of previous cardiac surgery
  • Severe organ dysfunction

Sites / Locations

  • Fuwai HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Left Atrial Appendage Resection

off-pump coronary artery bypass

Arm Description

Outcomes

Primary Outcome Measures

postoperative new-onset atrial fibrillation
Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF.

Secondary Outcome Measures

stroke
Stroke is caused by a disruption in the flow of blood to part of the brain either because of occlusion of a blood vessel in the case of acute ischemic stroke (AIS) or the rupture of a blood vessel causing bleeding in or around the brain: intracerebral hemorrhage (ICH)or subarachnoid hemorrhage (SAH)。

Full Information

First Posted
January 5, 2020
Last Updated
January 19, 2021
Sponsor
China National Center for Cardiovascular Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT04220047
Brief Title
Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass
Official Title
Fuwai Hospital, Chinese Academy of Medical Science
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2026 (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
Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative atrial fibrillation.New-onset atrial fibrillation (NOAF) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.Marshall ligament amputation may reduce the occurence of atrial fibrillation. However, little is known whether this approach is justified during the coronary artery bypass graft.Therefore, this study aimed to investigate whether LAAO and Marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Stroke, Atrial Fibrillation
Keywords
off-pump coronary artery bypass, postoperative new-onset atrial fibrillation, left atrial appendage, Marshall ligament

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Left Atrial Appendage Resection
Arm Type
Experimental
Arm Title
off-pump coronary artery bypass
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Left Atrial Appendage Resection and Marshall Ligament Amputation
Intervention Description
Left Atrial Appendage Resection and Marshall Ligament Amputation during the cardiac surgery
Primary Outcome Measure Information:
Title
postoperative new-onset atrial fibrillation
Description
Postoperative atrial fibrillation (POAF), defined as new-onset atrial fibrillation (AF) in the immediate period after surgery, is the most important type of secondary AF.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
stroke
Description
Stroke is caused by a disruption in the flow of blood to part of the brain either because of occlusion of a blood vessel in the case of acute ischemic stroke (AIS) or the rupture of a blood vessel causing bleeding in or around the brain: intracerebral hemorrhage (ICH)or subarachnoid hemorrhage (SAH)。
Time Frame
1 months,3 months, 1years, 3years, 5years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: isolated first off-pump coronary artery bypass Exclusion Criteria: Preoperative atrial fibrillation or a history of atrial fibrillation; Concurrent cardiac or non-cardiac surgery Intraoperative convert to bypass bypass surgery Emergency surgery History of previous cardiac surgery Severe organ dysfunction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hengchao Wu, doctor
Phone
010-88322355
Email
whcwuhengchao@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansong Sun, doctor
Organizational Affiliation
Fuwai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hansong Sun, doctor

12. IPD Sharing Statement

Learn more about this trial

Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass

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