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USIM-LAAO: Evaluation of 3D Simulation and Planning of Left Atrial Appendage Occlusion Based on 3D Echocardiography

Sponsor
Universitair Ziekenhuis Brussel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05926037
Collaborator
(none)
30
Enrollment
15
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to compare a semi-automatic 3D echocardiography-based left atrial appendix occlusion procedure planning with FEops, with other imaging modalities for evaluating the left atrial appendage dimensions and device prediction (sizing, deformation) pre-left atrial appendix occlusion , including the current "gold standard", CT- based FEops HEARTguideTM left atrial appendix occlusion procedure planning. A number of pre-specified endpoints are defined for analyzing this new approach.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    First, we will compare dimensions of left atrial appendix ostium and device landing zone, and the predicted device size and deformation based on the gold standard (CT-based analysis by FEops HEARTguideTM, with ostium and landing zone dimensions, predicted device size (based on the device sizing chart) and device deformation predicted by FEops analysis of the 3D echo images. Complementary, dimensions and device size prediction derived from 3D echo-derived FEops analysis, will also be compared to measurements and device size prediction obtained from pre-procedural CT images and the 2D per-procedural transesophageal echocardiographic evaluation.

    Secondly, the process of echo image analysis by FEops will be tested by evaluating the percent-age of cases where FEops anatomical analysis is successful in providing a complete report. Based on the acquired 3D echo data, case processing is considered successful if ostium and landing zone diameters (minimum, maximum, mean and perimeter-based diameter), and device sizing, together with predicted device deformation, can be reported. The number of cases where only partial reporting is possible, as well the cases where no reporting is feasible, will also be recorded. If case analysis is not successful, the reason for failure will be reported.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of 3D Simulation and Planning of Left Atrial Appendage Occlusion Based on 3D Echocardiography
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Jul 31, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Level of agreement between dimensions (minimal, maximum, mean and perimeter-based diameter of ostium and landing zone) of FEops analysis based on 3D echocar-diography vs FEops analysis based on CT [DURING PROCEDURE]

    Secondary Outcome Measures

    1. Level of agreement between predicted device size by FEops analysis based on 3D echo vs FEops analysis based on CT [DURING PROCEDURE]

    2. Level of agreement between predicted device deformation by analysis based on 3D echo vs FEops analysis based on CT [DURING PROCEDURE]

    3. Level of agreement between dimensions (minimal, maximum, mean and perimeter-based diameter of ostium and landing zone) of FEops analysis based on 3D echo vs analysis based on 2D measurements on CT and peri-procedural echo [DURING PROCEDURE]

    4. Level of agreement between predicted device size by FEops analysis based on 3D echo vs FEops analysis based on 2D measurements on CT and peri-procedural echo [DURING PROCEDURE]

    5. The percentage of 3D echocardiography cases sent to FEops, where data on ostium and landing zone diameters, and device size prediction/deformation, can successfully be provided (descriptive) [DURING PROCEDURE]

    6. The percentage of 3D echocardiography cases sent to FEops, where data on ostium and landing zone diameters, and device size prediction/deformation, can only be par-tially, or are failed to be provided (descriptive) [DURING PROCEDURE]

    7. Most frequent reasons for failure to provide complete reporting after FEops analysis based on 3D echo images [DURING PROCEDURE]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Patients planned for LAAO with an Amplatzer Amulet Left Atrial Appendage Occluder (Abbott Medical) in 2 experienced Belgian LAAO centers. Patients will be selected for the procedure based on clinical indications, in line with currently accepted indications and national reimbursement criteria.

    Exclusion Criteria:

    Patients with contra-indication for contrast (including contrast allergy and renal failure), or radiation exposure (e.g. pregnancy) will be excluded from the trial. Inability by FEops to analyze CT images and provide a report, will also lead to trial exclusion.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universitair Ziekenhuis Brussel

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universitair Ziekenhuis Brussel
    ClinicalTrials.gov Identifier:
    NCT05926037
    Other Study ID Numbers:
    • 23203_USIM-LAAO
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 3, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of Jul 3, 2023