Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion

Официальное название

Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial

Обзор

The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis. The primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance. Participants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.

Подробное описание

The ACE-DOUBLE trial will be a multicentre, registry nested, block randomized, open label clinical trial comparing routine versus discretionary balloon post-dilation strategies following TAVI using the SAPIEN 3 balloon-expandable THV for severe aortic stenosis (AS).

Patients with severe symptomatic aortic valve disease that are accepted for TAVI using a balloon-expandable THV. Currently, the only balloon-expandable THV in routine clinical practice in Australia are the Sapien 3 Ultra and Sapien 3 Ultra Resilia (Edwards Lifesciences, Irvine CA, USA). Patients will be recruited from three TAVI centres participating in the ACE registry: The Alfred Hospital, Cabrini Hospital and Epworth Hospital are all located in Melbourne, Australia.

Specific sub-groups may benefit more from balloon post-dilation (BPD), and hence exploratory analyses will be performed to examine the effect of BPD on primary endpoints in the following subgroups:

* Male vs Female * Pre-dilation vs no pre-dilation * Tricuspid vs bicuspid aortic valve * Very severe AS (mean pressure gradient \> 50mmHg) * Very aortic valve high calcium score (\>3000 in males, \>1900 in females)

Вмешательства

• Другое 'Double tap' balloon post-dilation
  Routine second inflation of the valve delivery balloon ('double-tap') BPD following balloon-expandable valve TAVI

Первичные конечные точки

• Fluoroscopic valve expansion [Срок оценки: Day 1 post-procedure]

Вторичные конечные точки (3)

• Haemodynamic performance [Срок оценки: Day 1-3 post-procedure]
• Haemodynamic performance [Срок оценки: Day 1-3 post-procedure]
• Freedom from cardiovascular death or valve reintervention [Срок оценки: 1 year and 3 years post-procedure]

Критерии участия

Критерии включения

• Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra/RESILIA balloon-expandable transcatheter heart valve.
• Tricuspid or bicuspid aortic valve stenosis

Критерии исключения

• Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure
• TAVI performed for native valve aortic regurgitation
• High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Австралия · 3 центра

• Cabrini Hospital — Malvern
• The Alfred Hospital — Melbourne
• Epworth Hospital — Richmond

Идентификаторы

NCT: NCT07430267 · 058-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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