Идёт набор NCT07646704

HeartR™ PDA Occluder Post-Market Follow-Up Study

— Наблюдательное Patent Ductus Arteriosus

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: HeartR™ PDA Occluder.
Кому может быть актуально: Состояния в реестре: Patent Ductus Arteriosus. Базовые параметры: от 6 мес. · 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: Индонезия
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

The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and performance of the Lifetech HeartR™ PDA Occluder in real-world clinical practice in Indonesia. A total of 140 subjects diagnosed with Patent Ductus Arteriosus (PDA) and treated with the HeartR™ PDA Occluder according to the Instructions for Use (IFU) will be enrolled. Eligible subjects include patients aged ≥6 months, weighing ≥6 kg, with a PDA narrowest diameter ≥2 mm at the time of implantation. Patients without any follow-up visit after hospital discharge will be excluded from the study. The primary endpoint is procedural success at 12 months post-implantation, defined as the absence of major adverse events including stroke/TIA, device embolization, cardiac or vascular perforation, left pulmonary artery stenosis or aortic stenosis requiring re-intervention, and procedure/device-related death, together with complete defect closure confirmed by Doppler echocardiography without residual shunt. Secondary endpoints include complete closure rates before discharge and at 6 months post-implantation, incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention, incidence of device- or procedure-related adverse events (AEs) and serious adverse events (SAEs), as well as all-cause mortality through 24 months post-implantation.

Вмешательства

Устройство HeartR™ PDA Occluder
Lifetech HeartR™ PDA Occluder used for transcatheter closure of Patent Ductus Arteriosus (PDA).

Первичные конечные точки

Procedural success [Срок оценки: 12 months post-implantation]

Вторичные конечные точки (5)

Complete closure of the defects with no residual shunt [Срок оценки: before discharge and at 6 months post-implantation]
Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention [Срок оценки: before discharge and at 6 months, 12 months post-implantation]
Incidence of device or procedure related Adverse Events (AEs) [Срок оценки: from attempted procedure to 24 months post-implantation]
Incidence of device or procedure related Serious Adverse Events (SAEs) [Срок оценки: from attempted procedure to 24 months post-implantation]
Incidence of death [Срок оценки: from attempted procedure to 24 months post-implantation]

Критерии участия

Критерии включения

Patients with a confirmed diagnosis of Patent Ductus Arteriosus (PDA) and were implanted with the HeartR™ PDA Occluder as per IFU instructions
Age ≥ 6 months at the time of implantation.
Weighing ≥ 6 kg at the time of implantation.
Narrowest portion of the PDA ≥ 2mm at the time of implantation.