Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention (ASSEE-SHD)
Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
This study aims to establish an active surveillance system to evaluate the safety and effectiveness of innovative medical devices used in the interventional treatment of structural heart disease. The devices of interest include a biodegradable patent foramen ovale (PFO) closure device and a transcatheter mitral valve edge-to-edge repair system. Clinical information from patients receiving these devices during routine clinical care will be collected and analyzed. The findings will help evaluate the safety and effectiveness of these devices and support the development of appropriate clinical evaluation indicators and long-term monitoring strategies.
Visão geral do estudo
Status
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Xinyi Xu
- Número de telefone: +86 18930830756
- E-mail: 3342@scmc.com.cn
Estude backup de contato
- Nome: Kai Wang
- Número de telefone: +86 15317921903
- E-mail: 30192@scmc.com.cn
Locais de estudo
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Beijing, China
- Ainda não está recrutando
- Beijing Anzhen Hospital, Capital Medical University
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Contato:
- Yizhen Yang
- Número de telefone: +86 13261985610
- E-mail: yangyizhen2005@126.com
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Investigador principal:
- Wenhui Wu
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Beijing, China
- Ainda não está recrutando
- FUWAI Hospital, CAMS&PUMC
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Contato:
- Jing Dong
- Número de telefone: +86 15810174302
- E-mail: Djing0324@163.com
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Investigador principal:
- Guangzhi Zhao
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Shanghai, China
- Ainda não está recrutando
- East Hospital, Tongji University
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Contato:
- Ying Hao
- Número de telefone: +86 18049898248
- E-mail: supergreathy@163.com
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Investigador principal:
- Linxiang Lu
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Gansu
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Lanzhou, Gansu, China
- Recrutamento
- The First Hospital of Lanzhou University
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Contato:
- Sixiong Hu
- Número de telefone: +86 17693433056
- E-mail: hsx1120587348@126.com
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Investigador principal:
- Jizhe Xu
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Guangdong
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Guangzhou, Guangdong, China
- Ainda não está recrutando
- Guangdong Provincial People's Hospital
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Contato:
- Xiaotong Wen
- Número de telefone: +86 18123548072
- E-mail: 1127337995@qq.com
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Investigador principal:
- Caojin Zhang
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Henan
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Zhengzhou, Henan, China
- Recrutamento
- Fuwai Central China Cardiovascular Hospital
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Contato:
- Menghao Li
- Número de telefone: +86 18790660032
- E-mail: edward564@163.com
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Investigador principal:
- Shubo Song
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Hubei
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Wuhan, Hubei, China
- Recrutamento
- Zhongnan Hospital of Wuhan University
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Contato:
- Lei Wang
- Número de telefone: +86 18702797617
- E-mail: 119559295@qq.com
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Investigador principal:
- Gangcheng Zhang
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Liaoning
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Shenyang, Liaoning, China
- Ainda não está recrutando
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
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Investigador principal:
- Qiguang Wang
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Contato:
- Jiawang Xiao
- Número de telefone: +86 17790991821
- E-mail: xjw492918837@126.com
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Shandong
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Jinan, Shandong, China
- Ainda não está recrutando
- Shandong Provincial Hospital
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Contato:
- mingliang Dong
- Número de telefone: +86 13573157896
- E-mail: dongmingliang2008@126.com
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Investigador principal:
- Anbiao Wang
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Sichuan
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Chengdu, Sichuan, China
- Ainda não está recrutando
- Sichuan Provincial People's Hospital
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Contato:
- Xuechun Sun
- Número de telefone: +86 18981838108
- E-mail: sunxchun@163.com
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Investigador principal:
- Yunshan Cao
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Yunnan
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Kunming, Yunnan, China
- Ainda não está recrutando
- Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
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Investigador principal:
- Cheng Wang
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Contato:
- Kairui Yang
- Número de telefone: +86 13987313055
- E-mail: 416719379@qq.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
- Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device.
- Transcatheter Mitral Valve Edge-to-Edge Repair (TEER) Cohort: Patients with functional or degenerative mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a TEER system.
Descrição
Inclusion Criteria:
- Patients undergoing implantation of a biodegradable PFO closure device.
- Patients undergoing transcatheter mitral valve edge-to-edge repair.
Exclusion Criteria:
The participant expresses a desire to withdraw from the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
|---|
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Biodegradable Patent Foramen Ovale Closure Device
Participants with patent foramen ovale (PFO) who receive a biodegradable PFO closure device as part of routine clinical care will be included in this cohort. Clinical data will be collected to evaluate the safety and effectiveness of the device during follow-up. |
|
Transcatheter Mitral Valve Edge-to-Edge Repair System Cohort
Participants with degenerative or functional mitral regurgitation who undergo transcatheter mitral valve edge-to-edge repair using a transcatheter mitral valve edge-to-edge repair system. Safety and effectiveness outcomes will be assessed during follow-up. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Major Adverse Events
Prazo: At 1, 6, and 12 months after the procedure
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Incidence of major adverse events related to the biodegradable PFO closure or transcatheter mitral valve edge-to-edge repair procedure during follow-up. |
At 1, 6, and 12 months after the procedure
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Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography
Prazo: At 1, 6, and 12 months after the procedure
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The proportion of participants achieving successful anatomical closure of the patent foramen ovale (PFO) during the 12-month follow-up period after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography. |
At 1, 6, and 12 months after the procedure
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Incidence of the composite clinical outcome of heart failure hospitalization, all-cause mortality, or cardiovascular mortality within 12 months after transcatheter edge-to-edge mitral valve repair
Prazo: At 1, 6, and 12 months after the procedure
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The proportion of participants experiencing at least one of the following events during the 12-month follow-up period after TEER: hospitalization for heart failure, all-cause death, or cardiovascular death. Events will be assessed through clinical follow-up and review of medical records. |
At 1, 6, and 12 months after the procedure
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Degree of device degradation
Prazo: At 1, 6, and 12 months after the procedure
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The degree of degradation of the biodegradable PFO closure device will be assessed by echocardiography during follow-up. |
At 1, 6, and 12 months after the procedure
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Incidence of residual shunt after PFO closure
Prazo: At 1, 6, and 12 months after the procedure.
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The presence of residual shunt after implantation of the biodegradable PFO closure device will be assessed by echocardiography with contrast study, when applicable. |
At 1, 6, and 12 months after the procedure.
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Incidence of re-intervention after PFO closure
Prazo: At 1, 6, and 12 months after the procedure.
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The percentage of participants requiring reapeat intervention or surgical treatment related to the PFO closure device during follow-up. |
At 1, 6, and 12 months after the procedure.
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Incidence of recurrent stroke after PFO closure
Prazo: At 1, 6, and 12 months after the procedure.
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The occurrence of recurrent ischemic or hemorrhagic stroke during the follow-up period will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
|
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Incidence of device-related thrombosis after PFO closure
Prazo: At 1, 6, and 12 months after the procedure.
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The occurrence of thrombosis related to the biodegradable PFO closure device during follow-up will be assessed by echocardiography and clinical assessment. |
At 1, 6, and 12 months after the procedure.
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Proportion of participants who underwent TEER and achieved immediate procedural success
Prazo: Within 24 hours after the procedure.
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Immediate procedural success is defined as successful completion of the transcatheter mitral valve edge-to-edge repair procedure with post-procedural mitral regurgitation (MR) grade ≤2+, as assessed by echocardiography. |
Within 24 hours after the procedure.
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Incidence of subsequent open-heart surgery in the TEER group
Prazo: At 1, 6, and 12 months after the procedure.
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The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up. |
At 1, 6, and 12 months after the procedure.
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Incidence of ischemic or hemorrhagic stroke in the TEER group
Prazo: At 1, 6, and 12 months after the procedure.
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The occurrence of ischemic or hemorrhagic stroke during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
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Incidence of bleeding events in the TEER group
Prazo: At 1, 6, and 12 months after the procedure.
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The occurrence of bleeding events during follow-up in the TEER group will be assessed by clinical evaluation and review of medical records. |
At 1, 6, and 12 months after the procedure.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lijun Fu, Shanghai Children's Medical Center
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
Outros números de identificação do estudo
- SCMC2024ZD0527503
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual participant-level data relevant to the study objectives, including baseline characteristics, procedural data, safety and efficacy outcomes, and follow-up data, will be shared.
Prazo de Compartilhamento de IPD
Start Date: 12 months after publication of the primary results End Date: No end date
Critérios de acesso de compartilhamento IPD
De-identified individual participant-level data and supporting information will be available to qualified researchers upon reasonable request and subject to review and approval by the study investigators. Access will be provided for scientifically justified research purposes in accordance with applicable regulations and data protection requirements. Requests should be submitted to the study investigators, and approved data will be shared through a secure data transfer mechanism.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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