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

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease; Atrial Fibrillation; Stroke
• Interventions: Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation

• Registration Number: NCT04220047
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-05
• Study First Posted: 2020-01-07
• Study Start: 2020-04-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-19
• Last Update Posted: 2021-01-20
• Primary Completion: 2021-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left Atrial Appendage Resection	Left Atrial Appendage Resection and Marshall Ligament Amputation	-

Primary Outcome Measures

Name	Time	Method
postoperative new-onset atrial fibrillation	7 days	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

Name	Time	Method
stroke	1 months,3 months, 1years, 3years, 5years.	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）。

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, China