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.

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.

Study Overview

• Status: Unknown
• Conditions: Heart Surgery
• Intervention / Treatment: Procedure: Left atrial appendage occlusion surgery

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • Beijing Anzhen Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator	Procedure: Left atrial appendage occlusion surgery; CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage
NO_INTERVENTION: Sham Comparator

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• Investigators: Study Director: Ping Li, PHD, Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (ACTUAL): September 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: stroke; prevention; Coronary artery bypass graft; Left Atrial Appendage Occlusion
• Other Study ID Numbers: 20190926

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No