Surgical vs Percutaneous LAAO
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TEE
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Left Atrial Appendage Closure, Left Atrial Appendage Occlusion
Eligibility Criteria
Inclusion Criteria:
- Atrial fibrillation diagnosis
- Underwent LAA clip (Atriclip) or left atrial appendage occlusion with CHADVASC >=2
Exclusion Criteria:
- Subject not required anticoagulation due to low CHADVASC
- Mechanical valve replacement
- Tissue mitral valve replacement or tissue aortic valve replacement with underlying chronic rheumatic heart disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Left Atrial Appendage Occlusion
Left Atrial Appendage Closure,
Arm Description
Outcomes
Primary Outcome Measures
occlusion result
to compare the occlusion result of LAAC vs LAAO by transoesophageal echocardiogram.
Secondary Outcome Measures
Full Information
NCT ID
NCT05420701
First Posted
June 12, 2022
Last Updated
September 19, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05420701
Brief Title
Surgical vs Percutaneous LAAO
Official Title
A Study on Outcomes of Surgical and Percutaneous Left Atrial Appendage Closure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Atrial fibrillation is the most common cardiac arrythmia globally. Its prevalence ranges between 2-4% worldwide. It is associated with significant morbidity and mortality. One of the main concerns of AF is the risk of thromboembolism, which can result in debilitating or detrimental stroke. The gold standard for preventing AF stroke is long term oral anticoagulation in the form of warfarin or NOAC1,2.
Around 50% of patients who need anticoagulation are not on any form tablets and about 5% of patients who are not anticoagulated developed stroke. Some patients could not take anticoagulation because of high risk of bleeding, and this result in challenges within this cohort of patients. The left atrial appendage (LAA) is believed to be the main source of embolic in atrial fibrillation. The LAA is an anterolateral structure which is the smallest part of the left atrium. It originates anterior from the left pulmonary vein ostium. More than 90% of thromboembolic events happened in the LAA of non-rheumatic patients whereas only 57% of thrombi in rheumatic mitral valve disease3. This suggests that occluding the LAA is more beneficial in the non-valvular AF patients. Incomplete LAA closure is associated with a higher occurrence of thromboembolism. The growing evidence of LAA occlusion has been emerged. Percutaneous LAA Occlusion (LAAO) has been suggested that it may be considered for stroke prevention in patients with atrial fibrillation and contraindication for long term anticoagulation (class IIB, level B)1,2. This recommendation is based on the randomized controlled trials to show that percutaneous devices are non-inferior to oral anticoagulation in terms of preventing stroke in AF patients.
Surgical LAA clip occlusion (LAAC) has emerged as a potential method to isolate LAA to prevent thromboembolism. The recent LAAOS III trial shows that the risk of ischemic stroke or systemic embolism was lower with concomitant left atrial appendage occlusion performed during the surgery than without it, most of whom continued to receive ongoing anticoagulant therapy4. This reinforced the mechanistic value of occluding the LAA in prevention of stroke. However, the efficacy of isolated LAAC without anticoagulation is uncertain. Besides, as this surgical clip occlusion is frequently performed together with other concomitant cardiac surgery, post evaluation in the form of imaging is lacking. Our study aims to study the imaging follow-up result and clinical efficacy of surgical and percutaneous left atrial appendage closure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Left Atrial Appendage Closure, Left Atrial Appendage Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Left Atrial Appendage Occlusion
Arm Type
No Intervention
Arm Title
Left Atrial Appendage Closure,
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
TEE
Intervention Description
Patients in the surgical arm (LAAC) will be arranged to do TEE, which is not considered standard of care.
Primary Outcome Measure Information:
Title
occlusion result
Description
to compare the occlusion result of LAAC vs LAAO by transoesophageal echocardiogram.
Time Frame
around 1 year post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Atrial fibrillation diagnosis
Underwent LAA clip (Atriclip) or left atrial appendage occlusion with CHADVASC >=2
Exclusion Criteria:
Subject not required anticoagulation due to low CHADVASC
Mechanical valve replacement
Tissue mitral valve replacement or tissue aortic valve replacement with underlying chronic rheumatic heart disease
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Surgical vs Percutaneous LAAO
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