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

Stroke Clinical Trial

Official title:

Fuwai Hospital, Chinese Academy of Medical Science

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220047
• Other study ID #: 2019-1304
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2021
• Source: China National Center for Cardiovascular Diseases
• Contact: Hengchao Wu, doctor
• Phone: 010-88322355
• Email: whcwuhengchao[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Stroke

Intervention

Procedure:
• Left Atrial Appendage Resection and Marshall Ligament Amputation
Left Atrial Appendage Resection and Marshall Ligament Amputation during the cardiac surgery

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days
Secondary	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)?	1 months,3 months, 1years, 3years, 5years.