The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 86
- 试验地点
- 24
- 主要终点
- Freedom From Procedure- or Device-related Mortality at 30 Days.
研究概览
简要总结
The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.
详细描述
The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.
The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.
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
- •Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction >/= 30%
- •Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
- •Subject is willing to consent to participate
排除标准
- •Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
- •RVOT anatomy or morphology that is unfavorable for device anchoring
- •Positive pregnancy test
- •Life expectancy of less than 1 year
结局指标
主要结局
Freedom From Procedure- or Device-related Mortality at 30 Days.
时间窗: 30 days
The primary safety endpoint is point estimate of freedom from procedure or device-related mortality rate at 30 days post procedure.
Number of Participants With Acceptable Hemodynamic Function Composite at 6 Months
时间窗: 6 months
Defined as: * Mean RVOT gradient as measured by continuous-wave Doppler ≤40 mmHg -AND- * Pulmonary regurgitant fraction as measured by magnetic resonance imaging \<20%
次要结局
- Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)(At exit from catheterization lab/operating room (OR))
- Device Success Out to 5 Years(5 years)
- Number of Participants With Procedural Success at 30 Days(30 days)
- Assessment of Safety(Ongoing)
- Number of Participants With Technical Success at Exit From Catheterization Lab/Operating Room (OR)(At exit from catheterization lab/operating room (OR))
- Device Success Out to 5 Years(5 years)
- Number of Participants With Procedural Success at 30 Days(30 days)
- Freedom From TPV Dysfunction Out to 5 Years(5 years (5 year data has an anticipated reporting date of April 2026))
- Assessment of Safety(Ongoing)
- Characterization of Quality of Life Scores Out to 5 Years(4 Year, 5 Year (4 & 5 year data has an anticipated reporting date of April 2026))
- Characterization of Right Ventricle Remodeling Following TPV Implant(2 Year, 5 Year (2 & 5 year data has an anticipated reporting date of April 2026))