Implantation of the SAPIEN Transcatheter Heart Valve (THV) in the Pulmonic Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 13
- 主要终点
- Freedom From Device or Procedure Related Death or Reintervention
研究概览
简要总结
To assess the safety and effectiveness of pulmonic THV implantation in subjects with dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation (≥3+ pulmonary regurgitation) and/or RVOT conduit obstruction (mean gradient of >=35mmHg) by TTE.
详细描述
The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.
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
- •Weight must be equal to or exceed 35 kilograms.
- •In situ conduit size of ≥ 16 mm and ≤ 24 mm in diameter.
- •Subject presents with moderate or severe pulmonary regurgitation defined as ≥3+ pulmonary regurgitation by TTE or RVOT conduit obstruction with a mean gradient of >= 35 mmHg by TTE.
- •Subject is symptomatic as evidenced by cardiopulmonary exercise testing.
- •The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site.
- •The subject and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with protocol-required follow-up visits.
- •Catheterization is determined to be feasible by the treating physician.
排除标准
- •Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics)
- •Previously enrolled in this study.
- •Subject with pre-existing prosthetic heart valves in any position*.
- •Severe chest wall deformity.
- •Leukopenia (WBC<3000 mm3).
- •Acute or chronic anemia (Hb <9 g/dL).
结局指标
主要结局
Freedom From Device or Procedure Related Death or Reintervention
时间窗: 1 year
次要结局
- Freedom From MACCE(6 Months)
- Functional Improvement(6 months)