Melody(TM) Transcatheter Pulmonary Valve PB1016 Surveillance Study Implantation of the Medtronic Melody Transcatheter Pulmonary Valve PB1016 Using the Ensemble(TM) Transcatheter Delivery System in Patients With Dysfunctional RVOT Conduits
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 14
- 主要终点
- Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months
研究概览
简要总结
Non-randomized, multi-center, prospective surveillance study to investigate and assess the residual risks, and to confirm the currently established safety and performance of the Melody TPV PB1016.
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
- •Patient eligible to receive Melody TPV PB1016 per current Instructions for Use (IFU) indications at time of study enrollment
- •Patient (or patient's legally authorized representative) is willing to consent to participate in the study and will commit to completion of all follow-up requirements.
排除标准
- •Implantation in the aortic, tricuspid, 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
- •History of intravenous substance abuse
- •Currently participating in an investigational drug or device study
结局指标
主要结局
Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months
时间窗: 6 Months
Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation
次要结局
- Number of Subjects With Serious Procedure-related and Device-related Adverse Events(1 Year, 2 Years)
- Number of Subjects With Procedural Success(At Time Of Procedure)
- Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016(2 years)
- Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year(1 Year)
- Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years(2 Years)