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Surgical vs Percutaneous LAAO

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TEE
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

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

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 12, 2022
    Last Updated
    September 19, 2022
    Sponsor
    Chinese University of Hong Kong
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    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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