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

• Sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04108169
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Surgery	Procedure: Left atrial appendage occlusion surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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.
• Anticipated Study Start Date: Oct 1, 2019
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. All-cause death [3 year after discharge (These data is collected during follow-up visit at in-hospital)]

Secondary Outcome Measures

1. Atrial fibrillation [3 year after discharge (These data is collected during follow-up visit at in-hospital)]

2. Composite of ischemic stroke, thromboembolism and all death [3 year after discharge (These data is collected during follow-up visit at in-hospital)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Anzhen Hospital	Beijing		China	100029

Sponsors and Collaborators

• Beijing Institute of Heart, Lung and Blood Vessel Diseases

Investigators

• Study Director: Ping Li, PHD, Beijing Anzhen Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
• ClinicalTrials.gov Identifier: NCT04108169
• Other Study ID Numbers: 20190926
• First Posted: Sep 30, 2019
• Last Update Posted: Sep 30, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Beijing Institute of Heart, Lung and Blood Vessel Diseases: Coronary artery bypass graft; Left Atrial Appendage Occlusion; stroke; prevention

Study Results

No Results Posted as of Sep 30, 2019