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

Heart Surgery Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04108169
• Other study ID #: 20190926
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 2023

Study information

• Verified date: September 2019
• Source: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Contact: Yulin Li, PHD
• Phone: 86-010-64426153
• Email: lyllyl_1111[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2023
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Surgery

Intervention

Procedure:
• Left atrial appendage occlusion surgery
CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death		3 year after discharge (These data is collected during follow-up visit at in-hospital)
Secondary	Atrial fibrillation		3 year after discharge (These data is collected during follow-up visit at in-hospital)
Secondary	Composite of ischemic stroke, thromboembolism and all death		3 year after discharge (These data is collected during follow-up visit at in-hospital)