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

Sponsor

China National Center for Cardiovascular Diseases (Other)

Overall Status

Recruiting

CT.gov ID

NCT04220047

Collaborator

(none)

400

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Stroke Atrial Fibrillation	Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

Fuwai Hospital, Chinese Academy of Medical Science

Actual Study Start Date :

Apr 30, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Left Atrial Appendage Resection	Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation Left Atrial Appendage Resection and Marshall Ligament Amputation during the cardiac surgery
No Intervention: off-pump coronary artery bypass

Arm

Intervention/Treatment

Experimental: Left Atrial Appendage Resection

Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation

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

No Intervention: off-pump coronary artery bypass

Outcome Measures

Primary Outcome Measures

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

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）。

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing		China

Sponsors and Collaborators

China National Center for Cardiovascular Diseases

Investigators

Principal Investigator: Hansong Sun, doctor, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

China National Center for Cardiovascular Diseases

ClinicalTrials.gov Identifier:

NCT04220047

Other Study ID Numbers:

2019-1304

First Posted:

Jan 7, 2020

Last Update Posted:

Jan 20, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by China National Center for Cardiovascular Diseases

off-pump coronary artery bypass

postoperative new-onset atrial fibrillation

left atrial appendage

Marshall ligament

Additional relevant MeSH terms:

Atrial Fibrillation

Coronary Artery Disease

Study Results

No Results Posted as of Jan 20, 2021