Bioabsorbable Occluder for Outlet VSD: Safety and Aortic Valve Effects
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: transcatheter closure of outlet VSDs with bioabsorbable occluders.
- Кому может быть актуально
- Состояния в реестре: Congenital Heart Defects, VSD. Базовые параметры: от 1 год · 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Transcatheter Bioabsorbable Occluder Closure for Outlet Ventricular Septal Defect: Safety, Effectiveness and Impact on Aortic Valve Function
Обзор
This study aims to evaluate the efficacy and safety of transcatheter bioabsorbable occluder closure in patients with outlet-type ventricular septal defect (outlet VSD), with a focus on assessing its impact on aortic valve function.
Подробное описание
Outflow-type ventricular septal defects (outlet VSDs) represent a challenging subset of congenital heart defects due to their association with progressive aortic valve prolapse and regurgitation. While surgical repair remains the gold standard, no reliable occluder has been available for transcatheter closure of this defect subtype.
The anatomical proximity of outlet VSDs to the aortic valve has historically limited transcatheter interventions. Conventional eccentric metal occluders require strict patient selection, typically being feasible only in cases with small defects and minimal aortic valve prolapse. Moreover, long-term concerns persist regarding metal devices' impact on aortic valve function.
Bioabsorbable occluders have been clinically available for perimembranous VSD closure. Their soft material properties minimize mechanical trauma to the aortic valve, while gradual resorption over time may eliminate permanent device-related complications. However, robust data regarding their efficacy, safety, and long-term impact on aortic valve function in outlet VSDs remain lacking.
This study aims to evaluate the short- and long-term outcomes of bioabsorbable occluder closure in outlet VSD patients, with a focus on defect closure rates and aortic valve function preservation.
Вмешательства
- Устройство transcatheter closure of outlet VSDs with bioabsorbable occluders
Transcatheter closure of outlet ventricular septal defects using a bioabsorbable occluder (Shape Memory Alloy Ltd, Shanghai, China). Implantation is performed via femoral/transthoracic approach under echocardiographic guidance following standard interventional protocols.
Первичные конечные точки
- Number of participants with procedural success [Срок оценки: 12 months]
Вторичные конечные точки (8)
- Number of participants with technical success [Срок оценки: Intraprocedural]
- Number of participants with major adverse events [Срок оценки: 12/24/60 months]
- Closure Efficacy [Срок оценки: Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Aortic regurgitation severity [Срок оценки: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Pulmonary regurgitation severity [Срок оценки: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Left ventricular outflow tract (LVOT) velocity and pressure gradient [Срок оценки: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Right ventricular outflow tract （RVOT）velocity and pressure gradient [Срок оценки: Baseline, Intraprocedural, 72 hours post procedure, 1/3/6/12/24/60 months]
- Disc area quantification [Срок оценки: 72 hours post procedure, 1/3/6/12/24/60 months]
Критерии участия
Критерии включения
- Age ≥1 year and weight ≥10 kg
- Outlet VSD without ventricular malalignment
- Maximal defect diameter ≤12mm with subaortic rim ≤1mm and no ≥mild aortic regurgitation by by transthoracic or transesophageal echocardiography
- Written informed consent
Критерии исключения
- Outlet VSD with a fibrous postero-inferior rim
- Concurrent cardiac conditions requiring surgical correction
- Severe pulmonary hypertension (PVR > 5 WU, assessed by right heart catheterization )
- Intracardiac thrombus
- Pregnancy
- Active systemic infection within 1 month
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Китай · 1 центр
- The First Affiliated Hospital of Guangxi Medical University — Nanning
Идентификаторы
NCT: NCT07040579 · GXMU-VSDO-001