Establishment of Active Surveillance and Safety and Efficacy Evaluation Indicators for Innovative Devices Used in Interventional Treatment of Structural Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,200
- 试验地点
- 11
- 主要终点
- Incidence of Major Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing implantation of a biodegradable PFO closure device.
- •Patients undergoing transcatheter mitral valve edge-to-edge repair.
排除标准
- •The participant expresses a desire to withdraw from the study.
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of Major Adverse Events
时间窗: 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.
Anatomical success of PFO closure within 12 months after biodegradable PFO occluder implantation, assessed by transthoracic echocardiography
时间窗: 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.
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
时间窗: 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.
次要结局
- Degree of device degradation(At 1, 6, and 12 months after the procedure)
- Incidence of residual shunt after PFO closure(At 1, 6, and 12 months after the procedure.)
- Incidence of re-intervention after PFO closure(At 1, 6, and 12 months after the procedure.)
- Incidence of recurrent stroke after PFO closure(At 1, 6, and 12 months after the procedure.)
- Incidence of device-related thrombosis after PFO closure(At 1, 6, and 12 months after the procedure.)
- Proportion of participants who underwent TEER and achieved immediate procedural success(Within 24 hours after the procedure.)
- Incidence of subsequent open-heart surgery in the TEER group(At 1, 6, and 12 months after the procedure.)
- Incidence of ischemic or hemorrhagic stroke in the TEER group(At 1, 6, and 12 months after the procedure.)
- Incidence of bleeding events in the TEER group(At 1, 6, and 12 months after the procedure.)
研究者
Lijun Fu
Chief Physician
Shanghai Jiao Tong University School of Medicine