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NCT Number: NCT04220047

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

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.

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Key information

Conditions

Coronary Artery Disease Arrhythmias, Cardiac Arterial Occlusive Diseases Arteriosclerosis Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coronary Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fuwai Hospital

Beijing, China

Location status: Recruiting

Location contact

Hansong Sun, doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Left Atrial Appendage Resection and Marshall Ligament Amputation

Procedure

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

Primary outcomes

  1. postoperative new-onset atrial fibrillation

    Time frame: 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 outcomes

  1. stroke

    Time frame: 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）。

Study contacts

Contact information is provided by the study sponsor or research team.

Hengchao Wu, doctor

CONTACT

[email protected]

010-88322355

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Registry information

Official study title

Fuwai Hospital, Chinese Academy of Medical Science

Important dates

Study start
2020
Primary completion
2021
Study completion
2026
First posted
Jan 7, 2020
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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