NCT03405636撤回不适用
Prospective, Non-randomized, Open Label Clinical Study to Assess the Safety and Performance of the Xeltis Pulmonary Valved Conduit in Subjects Undergoing Right Ventricular Outflow Tract (RVOT) Reconstruction
Xeltis6 个研究点 分布在 4 个国家开始时间: 2020年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 6
- 主要终点
- Survival at 12 months follow up post implantation
研究概览
简要总结
This is a multi-center prospective, single-arm, non-randomized, open label study to assess safety and performance of the Xeltis Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
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
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
- •Male or Female.
- •Age < 22 years.
- •Right Ventricular to Pulmonary Artery mean gradient > 35mm Hg or moderate or severe Pulmonary regurgitation (≥3+), or have both.
- •The patient, and the patient's parent / legal representative where appropriate, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent by signing the approved informed consent form.
- •The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
排除标准
- •Need for or presence of prosthetic heart valve at other position
- •Need for concomitant surgical procedures (non-cardiac)
- •Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
- •Active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
- •Active endocarditis
- •Leukopenia, according to local laboratory evaluation of white blood cell count
- •Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
- •Thrombocytopenia, defined as Platelet count < 150,000/mm3 Patients can be transfused to meet eligibility criteria
- •Severe chest wall deformity, which would preclude placement of the PV conduit
- •Pulmonary hypertension (right ventricular systolic pressure ≥ half of systemic systolic pressure)
- •Right ventricular outflow tract aneurysm
- •Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
- •Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
- •Patient has chronic inflammatory / autoimmune disease
- •Need for emergency cardiac or vascular surgery or intervention
- •Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
- •Currently participating, or participated within the last 30 days, in an investigational drug or device study
- •Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
- •Females who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years
- •Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
结局指标
主要结局
Survival at 12 months follow up post implantation
时间窗: 12 months
Measured by the fact that the patient is still alive at the time of the 12 month FU visit
次要结局
- Mean pressure gradient across the area of conduit implantation (RV to PA) of less than 40 mm Hg at 12 months follow up(12 months)
- Pulmonary regurgitation of equal or less than moderate (≤40 %) at 12 months follow up(12 months)
- Freedom from device related death, intervention and/or reoperation at 12 months follow up(12 months)
研究者
研究点 (6)
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