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

NCT05926037 | Unknown

• 1 other identifier: 23203_USIM-LAAO
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION

Outcome Measures

Primary Outcomes (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 Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (2)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

RECRUITING

Central Study Contacts

Stijn Lochy, MD

CONTACT

03224776008; stijn.lochy@uzbrussel.be

Ingrid Lemoine

CONTACT

03224776008; ingrid.lemoine@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 3, 2023
• Study Start: September 26, 2023
• Primary Completion: July 31, 2024
• Study Completion: November 1, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)