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Идёт набор NCT06284837

Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?

Без фазы С лечением Valve Stenoses, Aortic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Access site.
Кому может быть актуально
Состояния в реестре: Valve Stenoses, Aortic. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австралия
Следующий шаг
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Обзор

Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.

Вмешательства

  • Другое Access site
    The SAFER-TAVI trial is randomized study comparing secondary access via a transradial versus transfemoral approach among patients undergoing transfemoral TAVI for aortic valve disease. Secondary access is gained along with primary access at the commencement of the TAVI procedure and is used for aortography before and after valve deployment and for assessment of the primary femoral access site after closure to confirm haemostasis. For patients assigned to radial access, the radial sheath will be

Первичные конечные точки

  • All clinically relevant bleeding and all vascular complications [Срок оценки: 30 days]
Вторичные конечные точки (12)
  • All clinically relevant bleeding (BARC ≥2), overall and by access site [Срок оценки: 30 days]
  • All vascular complications, overall and by access site [Срок оценки: 30 days]
  • All-cause death [Срок оценки: 30 days]
  • Stroke [Срок оценки: 30 days]
  • Myocardial infarction [Срок оценки: 30 days]
  • Major adverse cardiovascular events [Срок оценки: 30 days]
  • Length of stay post-procedure [Срок оценки: 30 days]
  • Overall procedure duration [Срок оценки: 1 day]
  • Radiation dose [Срок оценки: 1 day]
  • Conversion rate to alternative vascular access site [Срок оценки: 30 days]
  • Tertiary site utilised to treat vascular complication [Срок оценки: 30 days]
  • Failure to perform angiogram of primary access site at completion of TAVI [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Age >18 years
  • Undergoing transfemoral TAVI with any commercially available transcatheter heart valve
  • Suitable radial and secondary femoral access

Критерии исключения

  • Primary arterial access via surgical cut-down
  • Inadequate contralateral femoral artery access and/or bilateral radial artery access as determined by the interventional cardiologist
  • Previously failed attempt to access bilateral radial arteries.
  • Patient on hemodialysis

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
Другое

Центры проведения

Австралия · 3 центра
  • Alfred Health — Melbourne
  • Epworth Healthcare — Melbourne
  • Cabrini Health — Melbourne

Идентификаторы

NCT: NCT06284837 · HREC/99382/Alfred-2023

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗