Optimized Expansion of the Implanted Transcatheter Aortic Valve

Официальное название

Optimized Expansion of the Implanted Transcatheter Aortic Valve to Reduce Hypoattenuating Leaflet Thickening in Non-atrial Fibrillation Patients Undergoing Transcatheter Aortic Valve Implantation: an International, Multicentre, Randomized Controlled Trial

Обзор

Optimized Expansion of the implanted transcatheter aortic valve to reduce hypoattenuating leaflet thickening in non-atrial fibrillation patients undergoing transcatheter aortic valve implantation (TAVI): an international, multicentre, randomized controlled trial. The objective is to evaluate whether TAVI with systematic optimized pre- and post-dilatation (optimized expansion (OptEx) TAVI strategy), compared to a standard of care (SoC) TAVI strategy, is superior in reducing hypoattenuating leaflet thickening as evaluated by cardiac computed tomography (CT) imaging at three months after TAVI. The primary outcome is at least one thickened TAV leaflet involving ≥ 25% of the leaflet curvilinear dimension as assessed at cardiac CT at three months after TAVI.

Подробное описание

A total of 1010 patients will be included in the OptEx-TAVI trial and randomised 1:1 to either :

* SoC-TAVI (N = 505) or * OptEx-TAVI (N = 505)

All patients with indication for TAVI and eligible in relation to the study in- and exclusion criteria will be offered participation in the OptEx-TAVI trial.

Inclusion criteria:

* Severe native aortic valve stenosis * Indication for TAVI * Ability to understand and to comply with the study protocol

Exclusion criteria:

* Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve) * Creatinine clearance \<15 mL/min (CKD-EPI formula) or on renal replacement therapy * Iodine contrast allergy or other condition that prohibits cardiac CT imaging

Baseline characteristics, medical history, procedural details, electrocardiogram, echocardiography and cardiac CT-scan parameters will be recorded by assessing medical charts and patient interview.

During the TAVI-procedure, patients will be treated according to randomisation to either SoC or OptEx

Planned post-procedural visits at:

* Discharge: on-site - including transthoracic echocardiography (TTE) * 3 months visit (± 2 months): on-site - including TTE and cardiac CT scan * 1 year (± 3 months): on-site - including TTE and cardiac CT scan * 5 years (± 6 months): on-site - including TTE and cardiac positron emission tomography (PET)-CT scan

Вмешательства

• Процедура OptEx-TAVI
  During TAVI with either self-expanding or balloon-expandable TAVs: * Pre-dilatation: systematic pre-dilatation with an optimally-sized balloon. * Post-dilatation: systematic TAV post-dilatation with an optimally-sized balloon. Optimally-sized balloon: 1. The recommended balloon size used for pre- and post-dilatation is the perimeter-derived mean diameter of the native aortic annulus minus 1 mm and should never exceed the perimeter-derived mean diameter of the native aortic annulus. A smaller-
• Процедура SoC-TAVI
  During TAVI with either self-expanding or balloon-expandable TAVs: Pre-dilatation: optional, as per operator preference and post-dilatation: optional, as per operator preference. Operators are only encouraged to post-dilate the implanted TAV in case of ≥ moderate paravalvular regurgitation or a suboptimal transvalvular gradient. The balloon size used for pre- or post-dilatation is left at the operator's discretion.

Первичные конечные точки

• At least one TAV leaflet with HALT [Срок оценки: At three months after TAVI]

Вторичные конечные точки (12)

• HALT 50% [Срок оценки: At 3 months/At 1 year]
• HALT 25% [Срок оценки: At 3 months/At 1 year]
• HALT 50%, multiple [Срок оценки: At 3 months/At 1 year]
• Bioprosthetic leaflet micro-calcification target-to-background ratio [Срок оценки: At 5 years]
• Valve performance [Срок оценки: At 3 months/At 1 year]
• structural valve deterioration [Срок оценки: At 5 years]
• Bioprosthetic valve dysfunction (BVD) [Срок оценки: At 5 years]
• Bioprosthetic valve failure (BVF) [Срок оценки: At 5 years]
• Technical success [Срок оценки: Periprocedural]
• Device success [Срок оценки: At 3 months]
• Early safety [Срок оценки: At 3 months]
• Clinical efficacy [Срок оценки: At 1 year]

Критерии участия

Критерии включения

• Severe native aortic valve stenosis
• Indication for TAVI
• Ability to understand and to comply with the study protocol

Критерии исключения

• Existing indication for oral anticoagulation (e.g., atrial fibrillation, venous thromboembolism, antiphospholipid syndrome, mechanical mitral valve)
• Creatinine clearance <15 mL/min (CKD-EPI formula) or on renal replacement therapy
• Iodine contrast allergy or other condition that prohibits cardiac CT imaging

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 4 центра

• AZORG ziekenhuis — Aalst
• CHU Charleroi — Charleroi
• UZ Leuven — Leuven
• AZ Delta — Roeselare

Дания · 4 центра

• Skejby Hospital — Aa
• Aalborg University Hospital — Aalborg
• Rigshospitalet — Copenhagen
• Odense University Hospital — Odense C

Нидерланды · 4 центра

• UMC Amsterdam — Amsterdam
• University Medical Center Groningen — Groningen
• Leiden University Medical Center — Leiden
• St. Antonius Hospital — Nieuwegein

Норвегия · 2 центра

• Haukeland hospital — Haukeland
• Oslo universitetssygehus — Oslo

Швеция · 2 центра

• Sahlgrenska University Hospital — Gothenburg
• Skånes universitetssjukhus — Skåne

Финляндия · 1 центр

• Turku University Hospital — Turku

Идентификаторы

NCT: NCT07042529 · OptEx-TAVI Trial · H-25039123

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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