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

Официальное название

Preoperative CT-imaging with Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Mild to severe paravalvular regurgitation [Срок оценки: 30-days]

Вторичные конечные точки (12)

• Incidence of new conduction disorder (new-onset left bundle branch block or new-onset atrioventricular block) [Срок оценки: 30 days after TAVI]
• Need for permanent pacemaker implantation [Срок оценки: 30 days after TAVI]
• Preoperative valve size selection [Срок оценки: Preprocedural]
• Final valve size [Срок оценки: Perprocedural]
• Target implantation depth [Срок оценки: Preprocedural]
• Final implantation depth [Срок оценки: Perprocedural]
• Change of preoperative decision in choice of default transcather heart valve [Срок оценки: Preprocedural]
• Change of preoperative decision in valve size selection [Срок оценки: Preprocedural]
• Change of preoperative decision in target implantation depth [Срок оценки: Preprocedural]
• Failure to implant valve [Срок оценки: Preprocedural]
• Composite endpoint of major adverse cardiac and cerebrovascular events (MACCE) [Срок оценки: 30 days after TAVI]
• Quality of life assessed by the EuroQol questionnaire [Срок оценки: 90 days after TAVI]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Австрия · 1 центр

• Vienna General Hospital — Vienna

Нидерланды · 1 центр

• St. Antonius Hospital — Nieuwegein

Идентификаторы

NCT: NCT05788770 · NL77697.100.21

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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