Набор скоро начнётся NCT07054541

A Novel Echocardiography-Guided Strategy for Percutateous Closure of Atrial Septal Defect Assisted by PannaWire

Фаза IV С лечением Atrial Septal Defect (ASD)

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: Ultrasound-guided intervention with assistance of specialized instruments, fluoroscopy-guided intervention.
Кому может быть актуально: Состояния в реестре: Atrial Septal Defect (ASD). Базовые параметры: от 2 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: 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 →

Обзор

Atrial septal defect (ASD) is a common congenital heart disease, and percutaneous interventional therapy is the main and effective treatment. Traditional percutaneous closure procedures are performed under fluoroscopic guidance and require contrast agents. A retrospective analysis of over 20,000 adult patients with congenital heart disease revealed that even low-dose radiation exposure was significantly associated with an increased long-term risk of malignancy. Moreover, the use of contrast agents carries the risk of allergic reactions and kidney injury. Radiation and contrast agents not only pose iatrogenic harm to patients but also limit the use of interventional techniques in special populations, such as pregnant women, patients with contrast agent allergies, or those with renal insufficiency. To achieve radiation-free and contrast-free interventional closure procedures, researchers have developed ultrasound-guided percutaneous interventional techniques, yielding satisfactory treatment outcomes. In some cases, these techniques have even enabled cardiovascular procedures to be performed on an outpatient basis, significantly reducing hospitalization time and costs. This project proposes a large-sample, multicenter, prospective randomized controlled study to determine whether ultrasound-guided percutaneous intervention for ASD with the assistance of specialized instruments is non-inferior to traditional fluoroscopy-guided procedures, while also offering shorter hospital stays and lower medical expenses.In addition, patients with radiation contraindications or who refuse radiation therapy, and who are willing to undergo ultrasound-guided percutaneous atrial septal defect (ASD) closure with the assistance of dedicated devices, will be enrolled in a separate observational cohort (observational cohort study).

Вмешательства

Процедура Ultrasound-guided intervention with assistance of specialized instruments
After detailed evaluation, patients will undergo percutaneous ASD closure under pure ultrasound guidance in the entire process with assistance of specialized instruments
Процедура fluoroscopy-guided intervention
After detailed evaluation, patients randomized in this group will undergo percutaneous ASD closure under fluoroscopic guidance in the entire process

Первичные конечные точки

Procedural success rate [Срок оценки: Immediately after implantation]

Вторичные конечные точки (6)

Successful closure rate [Срок оценки: Immediately after implantation, at 30 days, at 3 months after implantation]
Composite of major adverse events [Срок оценки: At 3 months after implantation]
Composite of minor adverse events [Срок оценки: At 3 months after implantation]
Procedure time [Срок оценки: At discharge (assessed up to 3 months)]
Days of hospital stay [Срок оценки: At discharge (assessed up to 3 months)]
Hospitalization cost [Срок оценки: At discharge (assessed up to 3 months)]

Критерии участия

RCT Eligibility Criteria

Критерии включения

Age ≥ 2 years
Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm

Критерии исключения

Pregnant women
Contrast agent allergy
Renal insufficiency
Associated cardiac malformations requiring surgical intervention
Right-to-left shunt ASD
Ostium primum ASD and sinus venosus ASD
Any severe infection within one month before the procedure
Intracardiac thrombus

Cohort Eligibility Criteria：

Критерии включения

Age ≥ 2 years
Diagnosed with secundum-type atrial septal defect (ASD) with a diameter ≥ 6 mm and ≤ 36 mm, accompanied by right heart volume overload
The distance from the defect margin to the coronary sinus, inferior vena cava, superior vena cava, and pulmonary veins is ≥ 5 mm; the distance to the atrioventricular valve is ≥ 7 mm
Contraindications to radiation exposure or refusal to undergo fluoroscopy-guided procedures