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.
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2019
CompletedFirst Posted
Study publicly available on registry
September 30, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedSeptember 30, 2019
September 1, 2019
3 years
September 26, 2019
September 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause death
3 year after discharge (These data is collected during follow-up visit at in-hospital)
Secondary Outcomes (2)
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)
Study Arms (2)
Active Comparator
ACTIVE COMPARATORSham Comparator
NO INTERVENTIONInterventions
CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage
Eligibility Criteria
You may qualify if:
- Subject undergoing coronary artery bypass grafting according to clinical indications;
- Age is more than 18 and less than 80 years old;
- Male and non pregnancy female;
- Subject understands study requirements and agrees to sign an informed consent from prior to study procedures.
You may not qualify if:
- Pregnancy female;
- Participate in other clinical trial in the last 1 month.
- Subject doesn't agree to sign an informed consent from prior to study procedures.
- Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.
- New York Heart Association (NYHA) Class IV heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital
Beijing, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ping Li, PHD
Beijing Anzhen Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2019
First Posted
September 30, 2019
Study Start
October 1, 2019
Primary Completion
October 1, 2022
Study Completion
January 1, 2023
Last Updated
September 30, 2019
Record last verified: 2019-09