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

Romy Hegeman454 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

454

Conditions

Aortic Valve Stenosis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Vienna General Hospital

Vienna, Austria

RECRUITING

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Mild to severe paravalvular regurgitation

Time frame: 30-days

Secondary Outcomes

Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block)

Time frame: 30 days after TAVI

Need for permanent pacemaker implantation

Time frame: 30 days after TAVI

Preoperative valve size selection

Time frame: Preprocedural

Final valve size

Time frame: Perprocedural

Target implantation depth

Time frame: Preprocedural

Final implantation depth

Time frame: Perprocedural

Change of preoperative decision in choice of default transcather heart valve

Time frame: Preprocedural

Change of preoperative decision in valve size selection

Time frame: Preprocedural

Change of preoperative decision in target implantation depth

Time frame: Preprocedural

Failure to implant valve

Time frame: Preprocedural

Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE)

Including mortality, stroke, life-threatening bleeding, major vascular complications, valve-related dysfunction requiring repeat procedure (TAVR or SAVR), according to the VARC-3 criteria

Time frame: 30 days after TAVI

Quality of life assessed by the EuroQol questionnaire

EuroQol-5 Dimensions-5 Levels, lower levels refer to better outcomes. Visual analog scale (0-100). Higher scores refer to a better outcome.

Time frame: 90 days after TAVI

Quality of life assessed by the Kansas City Cardiomyopathy Questionnaire

All scores are represented on a 0-to-100-point scale. Higher score refers to preferabel outcomes.

Time frame: 90 days after TAVI

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts