NCT04220047

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
7mo left

Started Apr 2020

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Apr 2020Dec 2026

First Submitted

Initial submission to the registry

January 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 30, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

1.7 years

First QC Date

January 5, 2020

Last Update Submit

January 19, 2021

Conditions

Coronary Artery DiseaseStrokeAtrial Fibrillation

Keywords

off-pump coronary artery bypasspostoperative new-onset atrial fibrillationleft atrial appendageMarshall ligament

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • stroke

    1 months,3 months, 1years, 3years, 5years.

Study Arms (2)

Left Atrial Appendage Resection

EXPERIMENTAL
Procedure: Left Atrial Appendage Resection and Marshall Ligament Amputation

off-pump coronary artery bypass

NO INTERVENTION

Interventions

Left Atrial Appendage Resection and Marshall Ligament AmputationPROCEDURE

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

Left Atrial Appendage Resection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • isolated first off-pump coronary artery bypass

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseStrokeAtrial Fibrillation

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArrhythmias, CardiacPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hansong Sun, doctor

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hengchao Wu, doctor

CONTACT

010-88322355whcwuhengchao@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2020

First Posted

January 7, 2020

Study Start

April 30, 2020

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

January 20, 2021

Record last verified: 2021-01

Locations

CN(1)