UnknownNot Applicable

Evaluation of 3D Simulation and Planning of Left Atrial Appendage Occlusion Based on 3D Echocardiography

Belgium30 participantsStarted 2023-09-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patients planned for LAAO with an Amplatzer Amulet Left Atrial Appendage Occluder (Abbott Medical) * clinical indication (in line with currently accepted indications and national reimbursement criteria) * inclusion in 2 experienced Belgian LAAO centers (Brussels and Genk) Exclusion Criteria: * contra-indication for contrast (including contrast allergy and renal failure), * contra-indication for radiation exposure (e.g. pregnancy) * Inability by FEops to analyze CT images and provide a report

What they're measuring

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

Timeframe: DURING PROCEDURE

Trial details

NCT IDNCT05926037

SponsorUniversitair Ziekenhuis Brussel

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-07-31

Contact for this trial

Stijn Lochy, MD

03224776008 stijn.lochy@uzbrussel.be

View on ClinicalTrials.gov More ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION trials