MedTrace Logo

Preprocedural Assessment of Anatomy and Device Sizing With CT and 3D Simulation in Left Atrial Appendage Occlusion.

NCT04640051 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 102

Last updated 2024-03-08

No results posted yet for this study

Summary

The objectives of the current proposal are to analyse to what extend:

1. The use of 3D in silico simulation by FEops HEARTguide improves of influences the pre-procedural assessment and device size selection and to what extend it correlates with final implanted device size and depth compared to TEE, CT and angiography.
2. The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.

A total of 100 consecutive patients for the total registry, or 15 to 20 consecutive patients per center, with standard of care follow-up at ±6 weeks and 1 year post procedure.

Conditions

  • LAAO With Amplatzer Amulet

Interventions

PROCEDURE

LAAO

LAAO by use of 3D in silico simulation by FEops HEARTguide as part of the pre-procedural assessment and device size selection

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

  • Ian Buysschaert, MD, PhD · AZ Sint-Jan AV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2023-04-22
Completion
2024-01-12

Countries

  • Belgium

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04640051 on ClinicalTrials.gov