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

N/ARecruitingNCT04220047

China National Center for Cardiovascular Diseases400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

400

Conditions

Coronary Artery Disease Stroke Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 7 days

Secondary Outcomes

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）。

Time frame: 1 months,3 months, 1years, 3years, 5years.