Computational Simulation to Plan for Percutaneous Left Atrial Appendage Closure

Summary

To ensure a successful percutaneous left atrial appendage (LAA) closure, it is important to select the correct size of the closure device used for each patient. To define and measure the size of the LAA, 2D transesophageal echocardiography (TEE) has been typically used. An increasing number of hospitals recently switched to measure the size of the LAA using a cardiac computed tomography (CT) scan. Although this CT scan helps to better define and measure the LAA, it is still difficult to determine the exact anticipated 'landing zone' or 'position' of the closure device. A novel strategy of preprocedural planning includes the use of preoperative computer simulations based on CT imaging (Feops HEARTguideTM), where the device is deployed with a computer simulation into the patient-specific LAA anatomy to provide the operator both optimal and suboptimal scenario's showing different sizes and positions of the closure device.

The aim of this study is to assess whether use of FEops HEARTguide computer simulations based on cardiac CT-imaging can contribute to a better preprocedural planning and improved procedural outcomes of percutaneous LAA closure procedures with an Amplatzer Amulet device.

The PREDICT-LAA trial will investigate the possible positive effect of a computer simulation using a CT scan of the LAA performed prior to the procedure. The hypothesis is that by using this new computer simulation, better planning of the intervention can be obtained.

Conditions

• Atrial Fibrillation
• Stroke Prevention

Interventions

OTHER

Additional support for preoperative planning of LAA closure procedures

The results of the computational simulations provided by FEops HEARTguideTM will be used in the "computational simulation arm" as an additional preoperative planning tool and their potential added value will be assessed by comparison to the standard of care arm.

PROCEDURE

Left atrial appendage closure

Transcatheter device insertion to exclude the LAA from the cardiac circulation

Sponsors & Collaborators

• Feops

  collaborator INDUSTRY

• Abbott

  collaborator INDUSTRY

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Ole De Backer, MD, PhD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2021-12-31

Completion

2022-12-31

Countries

• Belgium
• Canada
• Denmark
• France
• Italy
• Spain
• Sweden

Study Locations