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

Not Applicable

• Conditions: Heart Surgery
• Interventions: Procedure: Left atrial appendage occlusion surgery

• Registration Number: NCT04108169
• Lead Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-27
• Last Update Submitted: 2019-09-27
• Study First Posted: 2019-09-30
• Last Update Posted: 2019-09-30
• Study Start: 2019-10-01
• Primary Completion: 2022-10-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	Left atrial appendage occlusion surgery	-

Primary Outcome Measures

Name	Time	Method
All-cause death	3 year after discharge (These data is collected during follow-up visit at in-hospital)

Secondary Outcome Measures

Name	Time	Method
Atrial fibrillation	3 year after discharge (These data is collected during follow-up visit at in-hospital)
Composite of ischemic stroke, thromboembolism and all death	3 year after discharge (These data is collected during follow-up visit at in-hospital)

Trial Locations

Locations (1)

Beijing Anzhen Hospital; 🇨🇳 Beijing, China