An Active Post-Market Surveillance Study Assessing the Real-World Clinical Applicability, Long-Term Safety, and Effectiveness of Innovative Medical Devices for Valvular Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5,500
- 试验地点
- 1
研究概览
简要总结
This prospective, multicenter, observational cohort study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices in China.
详细描述
This prospective, multicenter, observational registry study plans to consecutively enroll patients across 50 Chinese hospitals undergoing treatment with innovative heart valve devices-including transcatheter aortic valve replacement (TAVR), surgical aortic valve replacement (SAVR), transcatheter mitral valve edge-to-edge repair (TEER), and transcatheter tricuspid valve annuloplasty (TTVA) systems. By collecting comprehensive data on medical history, physical examinations, laboratory tests, echocardiography, computed tomography (CT), electrocardiogram (ECG), wearable synchronous electrocardiogram-phonocardiogram, procedural details, pharmacotherapy, as well as regular clinical and imaging follow-up, this study aims to establish a post-market registry framework to evaluate the real-world clinical applicability, long-term safety, and effectiveness of innovative heart valve devices.
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 with valvular heart disease (VHD) receiving treatment with prosthetic aortic valve replacement systems (transcatheter and surgical valves), transcatheter mitral valve edge-to-edge repair (TEER) systems, or transcatheter tricuspid valve annuloplasty systems
- •Age ≥ 18 years
- •Patients who voluntarily participate in the study and sign the informed consent form
- •Willing and able to comply with follow-up requirements
排除标准
- 未提供