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Идёт набор NCT06849635

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study

— Наблюдательное Atrial Septal Defect

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Atrial Septal Defect. Базовые параметры: Без ограничений · 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
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cera™ ASD Occluder Post-Market Clinical Follow-Up Study：A Multi-Center, Single-arm, Ambispective Post-Market Follow-Up Study

Обзор

The objective of this post-market study is to: * collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder * identify previously unknown side-effects

Подробное описание

Atrial Septal Defect (ASD) is a type of Congenital Heart Defects (CHD) that have the potential to be closed without open-heart surgery. The treatment of choice for ASD closure has long been surgical closure. An alternative is the use of percutaneous access and transcatheter occluder devices as a treatment option for ASD. With percutaneous closure a thoracotomy is no longer needed and this is associated with a decreased procedural time and shorter hospital stay. The Lifetech Cera™ ASD occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. In order to collect real-word clinical data and confirm the long-time safety and performance of the Lifetech Cera™ ASD Occluder, this post-market clinical follow-up study is planned under the Regulation (EU) 2017/745. The study intends to enroll 139 subjects. The anticipated enrollment period is approximately 1 years and subjects will be followed for 2 years (24 months) post-implantation.

Первичные конечные точки

  • Procedural success [Срок оценки: 6 months post-implantation]
Вторичные конечные точки (5)
  • Successful closure of the defects [Срок оценки: at procedure, discharge（up to 2 days）and 12 months post-implantation]
  • Incidence of new onset arrhythmia requiring medical treatment [Срок оценки: From attempted procedure to 2 years post-implantation]
  • Incidence of device or procedure related Adverse Events (AEs) [Срок оценки: From attempted procedure to 2 years post-implantation]
  • Incidence of device or procedure related Serious Adverse Events (SAEs) [Срок оценки: From attempted procedure to 2 years post-implantation]
  • Incidence of death [Срок оценки: From attempted procedure to 2 years post-implantation]

Критерии участия

Критерии включения

  • Patients with a confirmed diagnosis of secundum Atrial Septal Defect (ASD).
  • Patients was implanted with the study device from 01 Jan 2020 to 31 Dec 2023 as per IFU instructions.
  • Patients or legally authorized representative are willing to the collection and processing of his/her data or sign the Informed Consent.

Критерии исключения

  • Patients who have extensive congenital cardiac anomaly which can only be adequately repaired by cardiac surgery.
  • Patients who have sepsis within one month prior to implantation, or any systemic infection that can't be successfully treated prior to device placement.
  • Patients known to have a bleeding disorder, untreated ulcer or any other contraindications to aspirin therapy, unless another anti-platelet agent can be administered for 6 months.
  • Patients who have demonstrated intra-cardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi).
  • Patients whose size (i.e., too small to tolerate TEE probe, catheter size, etc.) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization.
  • Patients where the margins of the defect are less than 5mm from the coronary sinus, AV valves or right upper lobe pulmonary vein.
  • Patients did not conduct any follow up visit after hospital discharge.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 6 центров
  • G.V.M.Carint Hospital — Myszków
  • Centre for Invasive Cardiology, Electrotherapy and Angiology G.V.M.Carint-Oswiecim — Oświęcim
  • Subcarpathian Centre for Cardiovascular Intervention G.V.M.Carint -Sanok — Sanok
  • Polish-American Heart Clinics, Heart and Vascular Center in Tychy, American Heart of Polan — Tychy
  • Polish-American Heart Clinics 1st Department of Invasive Cardiology and Heart Failure in U — Ustroń
  • Dr. Tytus Chałubiński County Hospital — Zakopane

Идентификаторы

NCT: NCT06849635 · LT-TS-27-2025-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗