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.
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Xinyi Xu
- Número de teléfono: +86 18930830756
- Correo electrónico: 3342@scmc.com.cn
Copia de seguridad de contactos de estudio
- Nombre: Kai Wang
- Número de teléfono: +86 15317921903
- Correo electrónico: 30192@scmc.com.cn
Ubicaciones de estudio
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Beijing, Porcelana
- Aún no reclutando
- Beijing Anzhen Hospital, Capital Medical University
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Contacto:
- Yizhen Yang
- Número de teléfono: +86 13261985610
- Correo electrónico: yangyizhen2005@126.com
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Investigador principal:
- Wenhui Wu
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Beijing, Porcelana
- Aún no reclutando
- FUWAI Hospital, CAMS&PUMC
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Contacto:
- Jing Dong
- Número de teléfono: +86 15810174302
- Correo electrónico: Djing0324@163.com
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Investigador principal:
- Guangzhi Zhao
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Shanghai, Porcelana
- Aún no reclutando
- East Hospital, Tongji University
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Contacto:
- Ying Hao
- Número de teléfono: +86 18049898248
- Correo electrónico: supergreathy@163.com
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Investigador principal:
- Linxiang Lu
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Gansu
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Lanzhou, Gansu, Porcelana
- Reclutamiento
- The First Hospital of Lanzhou University
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Contacto:
- Sixiong Hu
- Número de teléfono: +86 17693433056
- Correo electrónico: hsx1120587348@126.com
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Investigador principal:
- Jizhe Xu
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Guangdong
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Guangzhou, Guangdong, Porcelana
- Aún no reclutando
- Guangdong Provincial People's Hospital
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Contacto:
- Xiaotong Wen
- Número de teléfono: +86 18123548072
- Correo electrónico: 1127337995@qq.com
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Investigador principal:
- Caojin Zhang
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Henan
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Zhengzhou, Henan, Porcelana
- Reclutamiento
- Fuwai Central China Cardiovascular Hospital
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Contacto:
- Menghao Li
- Número de teléfono: +86 18790660032
- Correo electrónico: edward564@163.com
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Investigador principal:
- Shubo Song
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Hubei
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Wuhan, Hubei, Porcelana
- Reclutamiento
- Zhongnan Hospital of Wuhan University
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Contacto:
- Lei Wang
- Número de teléfono: +86 18702797617
- Correo electrónico: 119559295@qq.com
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Investigador principal:
- Gangcheng Zhang
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Liaoning
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Shenyang, Liaoning, Porcelana
- Aún no reclutando
- General Hospital of Northern Theater Command, Chinese People's Liberation Army
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Investigador principal:
- Qiguang Wang
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Contacto:
- Jiawang Xiao
- Número de teléfono: +86 17790991821
- Correo electrónico: xjw492918837@126.com
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Shandong
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Jinan, Shandong, Porcelana
- Aún no reclutando
- Shandong Provincial Hospital
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Contacto:
- mingliang Dong
- Número de teléfono: +86 13573157896
- Correo electrónico: dongmingliang2008@126.com
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Investigador principal:
- Anbiao Wang
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Sichuan
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Chengdu, Sichuan, Porcelana
- Aún no reclutando
- Sichuan Provincial People's Hospital
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Contacto:
- Xuechun Sun
- Número de teléfono: +86 18981838108
- Correo electrónico: sunxchun@163.com
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Investigador principal:
- Yunshan Cao
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Yunnan
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Kunming, Yunnan, Porcelana
- Aún no reclutando
- 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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Contacto:
- Kairui Yang
- Número de teléfono: +86 13987313055
- Correo electrónico: 416719379@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
- 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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Major Adverse Events
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Degree of device degradation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- SCMC2024ZD0527503
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Start Date: 12 months after publication of the primary results End Date: No end date
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- RSC
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .