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

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.

Study Overview

• Status: Recruiting
• Conditions: ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION

Detailed Description

First, the investigator 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 percentage 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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Stijn Lochy, MD; Phone Number: 03224776008; Email: stijn.lochy@uzbrussel.be
• Study Contact Backup: Name: Ingrid Lemoine; Phone Number: 03224776008; Email: ingrid.lemoine@uzbrussel.be

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Recruiting
    • Universitair Ziekenhuis Brussel
    • Contact: Stijn Lochy, MD; Phone Number: +32 2 477 6008; Email: Stijn.Lochy@uzbrussel.be
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Recruiting
      • Ziekenhuis Oost-Limburg
      • Contact: Philippe Bertrand, MD; Phone Number: +32 89804212; Email: philippe.bertrand@zol.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients planned for LAAO with an Amplatzer Amulet Left Atrial Appendage Occluder (Abbott Medical) in 2 experienced Belgian LAAO centers.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Level of agreement between predicted device size by FEops analysis based on 3D echo vs FEops analysis based on CT	DURING PROCEDURE
Level of agreement between predicted device deformation by analysis based on 3D echo vs FEops analysis based on CT	DURING PROCEDURE
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
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
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
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
Most frequent reasons for failure to provide complete reporting after FEops analysis based on 3D echo images	DURING PROCEDURE

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 23203_USIM-LAAO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No