Implantation of the Medtronic Melody Transcatheter Pulmonary Valve in Patients With Dysfunctional Right Ventricular Outflow Tract (RVOT) Conduits: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 9
- 主要终点
- Kaplan-Meier Freedom From TPV Dysfunction
研究概览
简要总结
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives are to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
详细描述
The primary objective is to confirm the long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. The secondary objectives is to evaluate long-term functionality at 10 years and to assess safety, procedural success, and clinical utility of transcatheter implantation of the Melody TPV.
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
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 5 years of age
- •Weight greater than or equal to 30 kilograms
- •Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted, or a stented bioprosthesis with a rigid circumferential sewing ring in the RVOT that has an internal diameter greater than or equal to 18 mm and less than or equal to 22 mm when originally implanted.
- •Any of the following by transthoracic echocardiography:
- •For patients in New York Heart Association (NYHA) Classification II, III, or IV: Moderate (3+) or severe (4+) pulmonary regurgitation AND/OR Mean RVOT gradient greater than or equal to 35 mmHg
- •For patients in NYHA Classification I:Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction AND/OR Mean RVOT gradient greater or equal to 40 mmHg
排除标准
- •Active endocarditis
- •Major or progressive non-cardiac disease (liver failure, renal failure, cancer)that has a life expectancy of less than one year
- •Patient or guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
- •Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
- •Positive urine or serum pregnancy test 24 hours prior to procedure in female patients of child bearing potential
- •Known intravenous drug abuse
结局指标
主要结局
Kaplan-Meier Freedom From TPV Dysfunction
时间窗: 5 years
To assess whether long-term functionality of implantation of the Medtronic Melody TPV at 5 years is no worse than the historical control established through literature review. This study is designed to test the null hypothesis that the true freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is less than or equal to 36% (PControl). To reject the null hypothesis means that freedom from TPV dysfunction at 5 years after Melody implantation (PMelody) is greater than 36% (PControl). The null (H0) and alternative (HA) hypotheses are written as follows:H0: PMelody ≤ PControl and HA: PMelody \> PControl. TPV dysfunction is a composite outcome defined as the following: * Hemodynamic dysfunction of the TPV * Moderate or greater pulmonary regurgitation, and/or * Mean Right Ventricular Outflow Tract (RVOT) gradient greater than 40 mmHg * RVOT reoperation for conduit dysfunction or device-related reasons * Catheter re-intervention on the TPV
次要结局
- Kaplan-Meier Freedom From Major Stent Fracture at 10 Years(10 years)
- Procedural Success(Within 24 Hours post implant)
- Kaplan-Meier Freedom From Major Stent Fracture at 5 Years(5 years)
- Kaplan-Meier Freedom From Surgical Replacement of the RVOT Conduit(10 years)
- Kaplan-Meier Freedom From Death (All-cause, Procedural and Device-related)(10 years)
- Freedom From TPV Dysfunction at 10 Years(10 years)
- Serious Procedural Adverse Event (AE)(10 years)
- Serious Device-related Adverse Event(10 years)
- Kaplan-Meier Freedom From Catheter Re-intervention on TPV(10 years)
- Functional Assessment (NYHA Classification)(6 Months)