Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

454 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-06

Study Completion Date

2024-12-31

Brief Summary

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Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders.

The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguide™) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.

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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multicenter, multinational, randomized controlled, open-label, trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FEops HEARTGuide

Device selection using FEops HEARTGuide: 3D anatomical analysis and simulation of transcatheter aortic valve prosthesis prior to procedure based on computed tomography.

Group Type EXPERIMENTAL

FEops HEARTGuide

Intervention Type OTHER

FEops HEARTGuide added to routine preoperative CT imaging. Results of the computer modelling will be discussed with TAVR implanting team prior to and during the procedure.

Standard transcatheter aortic valve implantation (no FEops HEARTGuide)

Control: standard of care, CT based device selection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FEops HEARTGuide

FEops HEARTGuide added to routine preoperative CT imaging. Results of the computer modelling will be discussed with TAVR implanting team prior to and during the procedure.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary symptomatic severe aortic valve stenosis
* Accepted for TAVR, either by transfemoral, transsubclavian or transapical access
* Plan to implant one of the following transcatheter heart valves for which FEops HEARTguide™ is available (CoreValve™ Evolut™ R, and Evolut™ PRO and Evolut™ PRO+ (Medtronic, Minnesota, USA), ACURATE neo™ and ACURATE neo 2™ (Boston Scientific, Marlborough, MA, USA)
* Informed consent

Exclusion Criteria

* Previous surgical aortic valve replacement
* Permanent pacemaker at baseline
* Emergency procedure
* Poor CT image quality (disabling computer-simulation, i.e. generation of 3D anatomical models will not be possible with poor CT image quality), for example because of motion artifacts due to the presence of other implanted devices affecting the region of interest
* Patient who did not agree to the informed consent and/or refused to participate
* Patient unable to understand the informed consent/study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No