Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
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
- 28
- 主要终点
- PDS Registry: Acute PDS Success
研究概览
简要总结
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation (PR).
Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •Weight is ≥ 20 kg (44 lbs).
- •RVOT/PV with moderate or greater PR by TTE.
- •RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.
排除标准
- •Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
- •History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
- •Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder.
- •Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
- •Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
- •Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure
- •Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
- •History of or current intravenous drug use
- •Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
- •Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
- •Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated
- •Currently participating in an investigational drug or another device study [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
- •Positive urine or serum pregnancy test in female patients of child-bearing potential
- •Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy
结局指标
主要结局
PDS Registry: Acute PDS Success
时间窗: 24 hours
Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient \< 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation
Main Cohort: THV Dysfunction
时间窗: 6 months
Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient \>= 35mmHg via TTE
次要结局
- Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline(30 days)