HeartR™ PDA Occluder Post-Market Follow-Up Study
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Locais de estudo
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Riau
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Pekanbaru, Riau, Indonésia, 28156
- Recrutamento
- RS Awal Bros
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Contato:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
- Número de telefone: 0761-47333
- E-mail: mkt.pku@awalbros.com
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Investigador principal:
- Shirley Leonita Anggriawan, Dr. Sp.A (K)
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- 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.
Exclusion Criteria:
Patients did not conduct any follow up visit after hospital discharge.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Procedural success
Prazo: 12 months post-implantation
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12 months post-implantation
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Complete closure of the defects with no residual shunt
Prazo: before discharge and at 6 months post-implantation
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Complete closure of the defects with no residual shunt
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before discharge and at 6 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
Prazo: before discharge and at 6 months, 12 months post-implantation
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Incidence of left pulmonary artery stenosis or aortic stenosis requiring re-intervention
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before discharge and at 6 months, 12 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
Prazo: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Adverse Events (AEs)
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from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
Prazo: from attempted procedure to 24 months post-implantation
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Incidence of device or procedure related Serious Adverse Events (SAEs)
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from attempted procedure to 24 months post-implantation
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Incidence of death
Prazo: from attempted procedure to 24 months post-implantation
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Incidence of death
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from attempted procedure to 24 months post-implantation
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- LT-TS-2-2025-01
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