Autus Size-Adjustable Valve for Surgical Pulmonary Valve Replacement Pivotal 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
- 51
- 试验地点
- 23
- 主要终点
- Valve Implantation Primary Safety Endpoint
研究概览
简要总结
Prospective, single-arm, multi-center study to evaluate safety and effectiveness of the Autus Size-Adjustable Valve in pediatric patients aged 18 months to 16 years requiring surgical pulmonary valve replacement. The Autus Valve may be expanded pre-implant to match the subject's body size. Subjects will be evaluated prior to the Autus Valve implant procedure, immediately post-implant, at hospital discharge, 30 days, 6 months, and annually through 10 years.
The Autus Valve may be expanded post-implant via transcatheter balloon dilation to accommodate growth of the subject. In subjects who undergo a post-implant valve expansion, follow-up will continue for a minimum of 1 year after the post-implant valve expansion procedure.
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
- 18 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.
- •Age 18 months to 16 years.
- •Male or female.
- •Subject has a native or repaired right ventricular outflow tract.
- •Subject has been recommended for surgical pulmonary valve replacement by treating clinical team (cardiologist and cardiac surgeon).
- •Subject has at least one of the following echocardiographic findings:
- •Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60 mmHg);
- •Moderate or greater pulmonary regurgitation;
- •Moderate or greater pulmonary stenosis plus moderate or greater pulmonary regurgitation.
- •Subject's body size is suitable for implantation of a study device ranging from 12.7 to 22 mm (internal diameter).
- •Subject and parent/legal representative, where appropriate, are willing to provide informed written consent.
- •Subject and parent/legal representative, where appropriate, and treating physician agree that the subject will return for, and comply with, all required study assessments and follow-up visits.
排除标准
- •Candidates will be excluded from the study if any of the following conditions are met:
- •Subject requires valve replacement in a non-pulmonary position.
- •Subject has a prosthetic valve at other valve position or will need a prosthetic valve at other valve position (i.e., anticipate additional valve replacements needed within 3 years).
- •Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).
- •Subject has pulmonary atresia and major aortopulmonary collaterals.
- •Subject has significant peripheral pulmonary artery stenosis.
- •Subject has an active infection requiring current systemic antibiotic therapy (if temporary illness, subject may be a candidate 4 weeks after discontinuation of antibiotics).
- •Subject has active endocarditis or a history of infective endocarditis.
- •Subject has renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renal disease.
- •Subject has leukopenia (defined as a white blood cell (WBC) count <3.5 x 103/µL)
- •Subject has acute or chronic anemia (defined as hemoglobin (Hgb) <10.0 g/dl or 6 mmol/L).
- •Subject has thrombocytopenia (defined as platelet count <50 x 103/µL.
- •Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.
- •Subject has a known autoimmune disease or receives immunosuppressant and/or immunostimulant drugs that the Investigator or Eligibility Screening Committee (ESC) believes may negatively affect study outcomes.
- •Subject needs emergency cardiac or vascular surgery or intervention.
- •Positive pregnancy test prior to valve implant procedure in female subjects who have had their first menses.
- •Subject has, in the opinion of the Investigator, a life expectancy of less than 5 years.
- •Subject or parent/legal representative refuses blood transfusions.
- •Subject has medical, social or psychosocial factors that, in the opinion of the Investigator or ESC, could impact safety or compliance with study procedures.
- •Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening.
研究组 & 干预措施
Autus Valve Arm
Pulmonary Valve Replacement Surgery with the Autus Valve
干预措施: Pulmonary Valve Replacement Surgery (Device)
结局指标
主要结局
Valve Implantation Primary Safety Endpoint
时间窗: 30 Days post-valve implantation
Composite Endpoint: Freedom from a device-related complication through 30 days post-valve implantation as adjudicated by an independent Clinical Events Committee (CEC), including: * Death; * Valve thrombosis requiring intervention; * Symptomatic thromboembolism.
Valve Implantation Primary Effectiveness Endpoint
时间窗: 6 Months post-valve implantation
Acceptable hemodynamic performance at 6 months post-valve implantation, as assessed by the Echocardiography Core Laboratory or Clinical Events Committee, defined as: * A mean RVOT gradient less than or equal to 40 mmHg and * Less than moderate pulmonary regurgitation by transthoracic echo and * No Autus Valve reintervention except for valve expansion to address prosthesis-patient mismatch.
次要结局
未报告次要终点