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Association Between S-LAAO and Adverse Cardiovascular Events Among Patients Undergoing Coronary Artery Bypass Grafting.

A Chinese Registry to Evaluate the Association of Surgical Left Atrial Appendage Occlusion vs No Receipt of S-LAAO With Adverse Cardiovascular Events Among Petients Undergoing Coronary Artery Bypass Grafting.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04108169
Enrollment
240
Registered
2019-09-30
Start date
2019-10-01
Completion date
2023-01-31
Last updated
2019-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgery

Keywords

Coronary artery bypass graft, Left Atrial Appendage Occlusion, stroke, prevention

Brief summary

This is a prospective, single-center, randomized, active controlled, clinical trail to assess the efficacy and safety of surgical closure of left atrial appendage (LAA) in patients undergoing coronary artery bypass graft.

Interventions

PROCEDURELeft atrial appendage occlusion surgery

CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage

Sponsors

Beijing Institute of Heart, Lung and Blood Vessel Diseases
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Subject undergoing coronary artery bypass grafting according to clinical indications; 2. Age is more than 18 and less than 80 years old; 3. Male and non pregnancy female; 4. Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion criteria

1. Pregnancy female; 2. Participate in other clinical trial in the last 1 month. 3. Subject doesn't agree to sign an informed consent from prior to study procedures. 4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery. 5. New York Heart Association (NYHA) Class IV heart failure.

Design outcomes

Primary

MeasureTime frame
All-cause death3 year after discharge (These data is collected during follow-up visit at in-hospital)

Secondary

MeasureTime frame
Composite of ischemic stroke, thromboembolism and all death3 year after discharge (These data is collected during follow-up visit at in-hospital)
Atrial fibrillation3 year after discharge (These data is collected during follow-up visit at in-hospital)

Countries

China

Contacts

Primary ContactYulin Li, PHD
lyllyl_1111@163.com86-010-64426153
Backup ContactPing Li, PHD
13520112185@163.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026