NCT05926037

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-07-31
• Completion: 2024-11-01
• First posted: 2023-07-03
• Last updated: 2023-12-12

Locations

2 sites across 1 country: Belgium