Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement (GUIDE-TAVI)

Romy Hegeman

Status: Enrolling

Conditions: Aortic Valve Stenosis

Treatments: Other: FEops HEARTGuide

Study type: Interventional

Funder types: Other

Identifiers

NCT05788770

NL77697.100.21

Details and patient eligibility

About

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.

Enrollment: 454 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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:a potential subject who meets any of the following criteria will be excluded from participation in this study before randomization:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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454 participants in 2 patient groups

FEops HEARTGuide

Experimental group

Description:

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

Treatment:

Other: FEops HEARTGuide

Standard transcatheter aortic valve implantation (no FEops HEARTGuide)

No Intervention group

Description:

Control: standard of care, CT based device selection.