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

NCT04640051 | Completed

• 1 other identifier: version 1.0 26/10/2020
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 6

Brief Summary

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

1. 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. 2.The use of 3D in silico simulation by FEops HEARTguide increases the operator's confidence in the device size selection.

Conditions

LAAO With Amplatzer Amulet

Outcome Measures

Primary Outcomes (1)

• Improvement in pre-procedural device size selection by use of FEops HEARTguide

  Correlation between device size selection by use of FEops HEARTguide and implanted device size

  At time of procedure

Study Arms (1)

LAAO group

Patients scheduled for LAAO with Amplatzer Amulet (Abbott) and for whom a 3D in silico simulation by FEops HEARTguide is available and reviewed before implantation

Procedure: LAAO

Interventions

LAAO PROCEDURE

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

LAAO group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 100 consecutive patients, schedule for LAAO with Amplatzer Amulet (Abbott) will be enrolled in this prospective registry after receiving signed informed consent.

You may qualify if:

• Patient signed informed consent
• Patient scheduled for LAAO with Amplatzer Amulet (Abbott)
• D in silico simulation by FEops HEARTguide available and reviewed before implantation

You may not qualify if:

• \- 3D in silico simulation by FEops HEARTguide not available or not reviewed before implantation

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (6)

ZNA Middelheim

Antwerp, Belgium

Location

AZ Sint-Jan Brugge-Oostende AV

Bruges, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

AZ Maria Middelares

Ghent, Belgium

Location

Sart Tilman - CHU de Liège

Liège, Belgium

Location

Related Publications (2)

• De Cock E, Lochy S, Rivero-Ayerza M, Lempereur M, Cornelis K, Debonnaire P, Vermeersch P, Christiaen E, Buysschaert I. Clinical Value of CT-Based 3D Computational Modeling in Left Atrial Appendage Occlusion: An In-Depth Analysis of the PRECISE LAAO Study. Catheter Cardiovasc Interv. 2025 May;105(6):1356-1364. doi: 10.1002/ccd.31464. Epub 2025 Feb 24.

  PMID: 39989438 DERIVED

• Swaans MJ, Huijboom MFM, Boersma LVA. Fluoroscopic Guidance: An Echo From the Past? JACC Cardiovasc Interv. 2021 Aug 23;14(16):1827-1829. doi: 10.1016/j.jcin.2021.07.003. No abstract available.

  PMID: 34412800 DERIVED

Study Officials

• Ian Buysschaert, MD, PhD

  AZ Sint-Jan AV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: July 2, 2021
• Primary Completion: April 22, 2023
• Study Completion: January 12, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

BE (6)