此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Active Surveillance and Safety/Efficacy Evaluation of Innovative Devices for Structural Heart Disease Intervention (ASSEE-SHD)

2026年9月26日 更新者：Lijun Fu、Shanghai Jiao Tong University School of Medicine

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.

研究概览

地位

招聘中

条件

研究类型

观察性的

注册 (估计的)

2200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Beijing、中国
        • 尚未招聘
        • Beijing Anzhen Hospital, Capital Medical University
        • 接触：
        • 首席研究员：
          • Wenhui Wu
      • Beijing、中国
        • 尚未招聘
        • FUWAI Hospital, CAMS&PUMC
        • 接触：
        • 首席研究员：
          • Guangzhi Zhao
      • Shanghai、中国
        • 尚未招聘
        • East Hospital, Tongji University
        • 接触：
        • 首席研究员：
          • Linxiang Lu
    • Gansu
      • Lanzhou、Gansu、中国
        • 招聘中
        • The First Hospital of Lanzhou University
        • 接触：
        • 首席研究员：
          • Jizhe Xu
    • Guangdong
      • Guangzhou、Guangdong、中国
        • 尚未招聘
        • Guangdong Provincial People's Hospital
        • 接触：
        • 首席研究员：
          • Caojin Zhang
    • Henan
      • Zhengzhou、Henan、中国
        • 招聘中
        • Fuwai Central China Cardiovascular Hospital
        • 接触：
        • 首席研究员：
          • Shubo Song
    • Hubei
      • Wuhan、Hubei、中国
        • 招聘中
        • Zhongnan Hospital of Wuhan University
        • 接触：
        • 首席研究员：
          • Gangcheng Zhang
    • Liaoning
      • Shenyang、Liaoning、中国
        • 尚未招聘
        • General Hospital of Northern Theater Command, Chinese People's Liberation Army
        • 首席研究员：
          • Qiguang Wang
        • 接触：
    • Shandong
      • Jinan、Shandong、中国
        • 尚未招聘
        • Shandong Provincial Hospital
        • 接触：
        • 首席研究员：
          • Anbiao Wang
    • Sichuan
      • Chengdu、Sichuan、中国
        • 尚未招聘
        • Sichuan Provincial People's Hospital
        • 接触：
        • 首席研究员：
          • Yunshan Cao
    • Yunnan
      • Kunming、Yunnan、中国
        • 尚未招聘
        • Fuwai Yunnan Hospital, Chinese Academy of Medical Sciences/Affiliated Cardiovascular Hospital of Kunming Medical University
        • 首席研究员：
          • Cheng Wang
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

  1. Biodegradable PFO Closure Device Cohort: Patients with confirmed PFO-associated ischemic stroke who undergo implantation of a biodegradable PFO closure device.
  2. 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.

描述

Inclusion Criteria:

  1. Patients undergoing implantation of a biodegradable PFO closure device.
  2. Patients undergoing transcatheter mitral valve edge-to-edge repair.

Exclusion Criteria:

The participant expresses a desire to withdraw from the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Major Adverse Events
大体时间：At 1, 6, and 12 months after the procedure

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
Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography
大体时间：At 1, 6, and 12 months after the procedure

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
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
大体时间：At 1, 6, and 12 months after the procedure

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

次要结果测量

结果测量
措施说明
大体时间
Degree of device degradation
大体时间：At 1, 6, and 12 months after the procedure

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
Incidence of residual shunt after PFO closure
大体时间：At 1, 6, and 12 months after the procedure.

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.
Incidence of re-intervention after PFO closure
大体时间：At 1, 6, and 12 months after the procedure.

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.
Incidence of recurrent stroke after PFO closure
大体时间：At 1, 6, and 12 months after the procedure.

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.
Incidence of device-related thrombosis after PFO closure
大体时间：At 1, 6, and 12 months after the procedure.

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.
Proportion of participants who underwent TEER and achieved immediate procedural success
大体时间：Within 24 hours after the procedure.

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.
Incidence of subsequent open-heart surgery in the TEER group
大体时间：At 1, 6, and 12 months after the procedure.

The number of participants undergoing subsequent open-heart surgery related to TEER during follow-up.
At 1, 6, and 12 months after the procedure.
Incidence of ischemic or hemorrhagic stroke in the TEER group
大体时间：At 1, 6, and 12 months after the procedure.

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.
Incidence of bleeding events in the TEER group
大体时间：At 1, 6, and 12 months after the procedure.

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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Shanghai Jiao Tong University School of Medicine

合作者

LanZhou University
Shandong Provincial Hospital
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Zhongnan Hospital
Chinese Academy of Medical Sciences, Fuwai Hospital
Sichuan Provincial People's Hospital
The General Hospital of Northern Theater Command
Shanghai East Hospital of Tongji University
ScienTech Medical
Valgen Medtech

调查人员

  • 首席研究员：Lijun Fu、Shanghai Children's Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年12月30日

初级完成 (估计的)

2029年1月31日

研究完成 (估计的)

2029年1月31日

研究注册日期

首次提交

2026年9月22日

首先提交符合 QC 标准的

2026年9月26日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月26日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • SCMC2024ZD0527503

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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.

IPD 共享时间框架

Start Date: 12 months after publication of the primary results End Date: No end date

IPD 共享访问标准

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.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅