Меню
Идёт набор NCT06871774

Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR

Без фазы С лечением Transcatheter Aortic Valve Replacement

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: Single Perclose Pro vascular closure device, Dual Perclose vascular closure device.
Кому может быть актуально
Состояния в реестре: Transcatheter Aortic Valve Replacement. 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
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Comparative Efficacy of Single vs. Dual Perclose Devices for Large-Bore Access Closure in Transcatheter Aortic Valve Replacement: A Randomized Controlled Trial

Обзор

This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.

Подробное описание

This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.

Вмешательства

  • Устройство Single Perclose Pro vascular closure device
    Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
  • Устройство Dual Perclose vascular closure device
    Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.

Первичные конечные точки

  • Number of Patients With Vascular Complications [Срок оценки: Day 5 post-procedure]
  • Number of Patients With Life-threatening bleeding [Срок оценки: Hour 24 post-procedure]
  • Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition [Срок оценки: Hour 24 post-procedure]
  • Time to Hemostasis [Срок оценки: 1 hour post procedure]
Вторичные конечные точки (4)
  • Additional Closure Device Use [Срок оценки: Hour 24 post-procedure]
  • In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions [Срок оценки: Day 5 post-procedure]
  • Number of Patients With Limb Ischemia Related to TAVR During Index Admission [Срок оценки: Day 5 post-procedure]
  • Limb Ischemia Related to TAVR [Срок оценки: Day 30 post-procedure]

Критерии участия

Критерии включения

  • Patient age 18 or older
  • Transfemoral transcatheter aortic valve replacement (TAVR)
  • Implantation of CoreValve replacement valve
  • Access using 14 French sheaths
  • English speaking

Критерии исключения

  • Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
  • Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
  • Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
  • Arterial or Venous Issues: Patients with small femoral arteries or veins (<5 mm in diameter), patients with access sites located in vascular grafts.
  • Body Composition: Patients with BMI >35
  • Cardiac Vasculature: Patients with excess calcification of vessels as determined by echocardiography and/or CT angiography
  • Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
  • Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count <100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
  • Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
  • Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
  • Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
  • Pregnancy and Lactation: Pregnant or lactating women.
  • Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
  • Contraindications: Patients with contraindications for the use of Perclose device.

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

США · 1 центр
  • Aurora St. Luke's Medical Center — Milwaukee

Идентификаторы

NCT: NCT06871774 · IRB00124842

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗