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

NCT ID: NCT04220047

Last Updated: 2021-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-30

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease Stroke Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Left Atrial Appendage Resection

Group Type EXPERIMENTAL

Left Atrial Appendage Resection and Marshall Ligament Amputation

Intervention Type PROCEDURE

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

off-pump coronary artery bypass

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Left Atrial Appendage Resection and Marshall Ligament Amputation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hansong Sun, doctor

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hengchao Wu, doctor

Role: CONTACT

010-88322355

Facility Contacts

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Hansong Sun, doctor

Role: primary

Other Identifiers

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2019-1304

Identifier Type: -

Identifier Source: org_study_id

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