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Recruiting NCT04220047

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

No phase Interventional Coronary Artery Disease Stroke Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Left Atrial Appendage Resection and Marshall Ligament Amputation.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Stroke, Atrial Fibrillation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Fuwai Hospital, Chinese Academy of Medical Science

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.

Interventions

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

Primary outcome measures

  • postoperative new-onset atrial fibrillation [Time frame: 7 days]
Secondary outcome measures (1)
  • stroke [Time frame: 1 months,3 months, 1years, 3years, 5years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Fuwai Hospital — Beijing

Identifiers

NCT: NCT04220047 · 2019-1304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗