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Идёт набор NCT06793969

Swartz Sheath With Angioplasty Guidewire-Assisted Technique for Patent Foramen Ovale Closure (STAGE-PFO)

Без фазы С лечением Patent Oval Foramen

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: Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage, Conventional technique to pass the PFO tunnel.
Кому может быть актуально
Состояния в реестре: Patent Oval Foramen. Базовые параметры: 18 лет — 65 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
Китай
Следующий шаг
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Официальное название

Swartz Sheath With Angioplasty Guidewire-Assisted Versus Conventional Technique for Patent Foramen Ovale Closure: A Multicenter Randomized Controlled Trial

Обзор

The technical challenge in patent foramen ovale (PFO) closure lies in successfully establishing an occlusion pathway through the PFO tunnel using a guidewire or catheter. In this study, we aim to investigate the efficacy and safety of Swartz sheath with angioplasty guidewire-assisted technique for PFO Closure.

Подробное описание

In cases of complex PFO, failure of guidewire passage through the septum can occur, rendering closure impossible. The present multicenter, prospective, randomized controlled trial aims to evaluate the efficacy and safety of a novel Swartz sheath with angioplasty guidewire-assisted technique to facilitate PFO tunnel passage.

With written consent, the investigators expect to enrol PFO patients with a history of cryptogenic stroke (CS) or transient ischemic attack (TIA), who requires PFO closure according to current guidelines. A standardized TEE protocol is used to assess the morphologic characteristics of the atrial septum and right-to-left shunting through PFO. Eligible patients are prospectively and randomly assigned to the Swartz sheath + angioplasty guidewire group or the conventional group (1:1 ratio). In the Swartz sheath + angioplasty guidewire group, the PFO closure procedure is performed with Swartz sheath + angioplasty guidewire assistance. In the conventional group, the PFO closure procedure is performed with a multi-functional catheter. After the procedure, safety parameters such as contrast use, procedure time, and severe complications are recorded. All patients are followed up at 1-, 3-, 6-, and 12- month post device implantation. The presence of a residual shunt, device embolization, device migration and residual shunt are recorded.

Вмешательства

  • Процедура Swartz sheath with Angioplasty Guidewire-Assisted Technique for PFO tunnel passage
    The angioplasty guidewire is advanced into the left atrium and left superior pulmonary vein (LSPV). The Swartz sheath is then delivered to the left atrium along the 0.014" guidewire through the PFO. Next, the Runthrough guidewire is changed to a 0.035" J-tipped guidewire, which is advanced into the LSPV. Finally, the delivery sheath for the PFO closure device is introduced to the left atrium along the guidewire, and all other toolkits are withdrawn.
  • Процедура Conventional technique to pass the PFO tunnel
    In the conventional group, the PFO closure procedure is performed with a multi-functional catheter and guided by intraprocedural fluoroscopy and ICE

Первичные конечные точки

  • Time of PFO tunnel passage [Срок оценки: Intraprocedural assessment (measured in minutes )]
Вторичные конечные точки (4)
  • Procedure Time [Срок оценки: Intraprocedural assessment (measured in minutes )]
  • Fluoroscopy Time [Срок оценки: Intraprocedural assessment (measured in minutes )]
  • Procedural Complications [Срок оценки: Intraprocedural assessment]
  • Radiation Dose [Срок оценки: Intraprocedural assessment (measured in mGys)]

Критерии участия

Критерии включения

  • Aged between 18 and 65
  • Confirmed diagnosis of PFO by transthoracic and transesophageal echocardiography
  • A history of cryptogenic stroke (CS) or transient ischemic attack (TIA)

Критерии исключения

  • Confirmed pregnancy
  • Confirmed diagnosis of intracardiac thrombosis
  • Confirmed diagnosis of pulmonary hypertension
  • Confirmed diagnosis of rheumatic heart disease, or valvular heart disease
  • Past medical history of myocardial infarction, unstable angina and intracranial hemorrhage

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

Китай · 1 центр
  • Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06793969 · STAGE-PFO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗