Implantation of the Medtronic Melody Transcatheter Pulmonary Valve (TPV) in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Post-Market Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 20
- 主要终点
- Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
研究概览
简要总结
The purpose of this study is to confirm the short-term hemodynamic effectiveness results achieved by real-world providers are equivalent to the historical control established in the IDE study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
- •Dysfunctional RVOT conduits with a clinical indication for intervention (regurgitation ≥ moderate regurgitation, Stenosis: mean RVOT gradient ≥ 35 mmHg)
排除标准
- •Implantation in the aortic or mitral position
- •Venous anatomy unable to accommodate a 22-fr size introducer sheath
- •Obstruction of the central veins
- •Clinical or biological signs of infection including active endocarditis
- •Unwilling or unable to provide written informed consent or comply with the follow-up requirements
研究组 & 干预措施
Melody TPV Implant
Melody® Transcatheter Pulmonary Valve implanted into a dysfunctional RVOT Conduit.
干预措施: Melody® Transcatheter Pulmonary Valve (Device)
结局指标
主要结局
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
时间窗: 6 months
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
次要结局
- Serious Device-related Adverse Events(6 months)
- Changes in NYHA Functional Classification(6 Months)
- Procedural Success(6 Months)
- Serious Procedural Adverse Events(6 Months)