Native Outflow Tract Transcatheter Pulmonary Valve Research Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Measurement of radial, linear and axial compression, bending and torsion of device
研究概览
简要总结
The purpose of this early feasibility study is to determine how a new transcatheter pulmonary valve will move and perform once implanted in the right ventricular outflow tract.
详细描述
Medtronic, Inc. is in the process of developing a novel transcatheter device option for patients with congenital heart disease, without right ventricle-to-pulmonary artery conduits, called the Native Outflow Tract Transcatheter Pulmonary Valve. Given limitations in the animal model to confirm device boundary conditions, this feasibility study is proposed to characterize that information as well as evaluate safety, procedural feasibility and performance data to be used for future development of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has pulmonary regurgitation as per one or more of the following criteria: Severe pulmonary regurgitation as measured by Doppler echocardiography, or Pulmonary regurgitant fraction ≥ 30% as measured by cardiac magnetic resonance imaging
- •Clinical indication for surgical placement of a RVOT conduit or bioprosthetic pulmonary valve per one or more of the following criteria: Subject is symptomatic secondary to pulmonary insufficiency (e.g. exercise intolerance, fluid overload) as classified by the Investigator, or Right ventricular end diastolic volume (RVEDV) ≥ 150 ml/m2
- •Subject is willing to consent to participate in the study and will commit to completion of all follow-up requirements
排除标准
- •Anatomy unable to accommodate a 25 Fr delivery system
- •Obstruction of the central veins
- •Clinical or biological signs of infection including active endocarditis
- •Indicated for intervention of stenosis of the branch pulmonary arteries at time of implant
- •Positive pregnancy test at baseline (prior to CT angiography and again prior to implant procedure) in female subjects of child bearing potential
- •Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with a right ventricle-to-pulmonary artery conduit implant
- •A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
- •Planned implantation of the Native Outflow Tract TPV in the left heart
- •RVOT anatomy or morphology that is unfavorable for anchoring
- •Known allergy to aspirin, heparin, or nickel
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Pre-existing prosthetic heart valve or prosthetic ring in any position
- •Patient is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial.
结局指标
主要结局
Measurement of radial, linear and axial compression, bending and torsion of device
时间窗: 4 Days Post-Implant
The following variables will be measured: radial compression, linear compression, axial compression, device bending and device torsion using the discharge CT. The degree of deformation of the device will be reported.
次要结局
- Pulmonary Regurgitation Severity as Measured by Echocardiography(Through 5 years)
- Mean RVOT Gradient (mmHg) as Measured by Color Wave Doppler(Through 5 years)
- Right Ventricular Volume (ml) as Measured by Cardiac MRI(Through 5 years)
- Number of Patients with Serious Procedural Adverse Events(Through 5 year follow-up)
- Number of Patients with Procedural Success(24 hours post-implant)
- Number of Patients with Device-related Adverse Events(Through 5 years)
- Number of Patients with Stent Fracture(Through 5 years)
- Number of Patients with Catheter Re-intervention on the TPV(Through 5 years)
- Assessment of Surgical Intervention on the TPV(Through 5 years)
- Number of Patient Deaths (all-cause, procedural, and device-related)(Through 5 years)
- Pulmonary Regurgitant Fraction (%) as measured by cardiac MRI(Through 5 years)