INSPIRIS RESILIA Valve in Pulmonary Position - A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Freedom from death and reoperation
研究概览
简要总结
In this trial we intend to evaluate the safety and effectiveness of the INSPIRIS valve prothesis in the pulmonary position in patients of five years or older, with congenital or acquired pulmonary valve disease, requiring replacement of their native or prosthetic pulmonary valve.
详细描述
Up to 40 subjects will be invited to participate in this trial after the indication for pulmonary valve replacement has been established. At the inclusion visit, patients will be screened according to the inclusion / exclusion criteria. After written informed consent, a detailed history will be obtained, and the study related exams will be performed.
The procedure will be performed through a median sternotomy with the help of cardiopulmonary bypass in a beating or arrested heart fashion depending on the individual surgeon's discretion. Any additional or residual defects will concomitantly be addressed. Either a native or prosthetic pulmonary valve will be replaced by an Edwards Inspiris valve (Edwards Lifesciences, Unterschleissheim, Germany). If a conduit is required, the valve will be sewn into a suitable prosthesis beforehand.
Subjects will be seen regularly after pulmonary valve implantation at hospital discharge, 6-month, 1 year and 2 years after surgery. A cardiac magnetic resonance imaging will be performed at inclusion and 2 years after surgery.
Total enrollment period for the study is estimated to be two years. The trial starts with the enrollment of the first patients and ends after the last patient enrolled has completed the two-year visit or has exited the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve, equal to or greater than five years of age.
- •Patients and/or patient´s legal representatives must provide written informed consent as approved and required by the respective institutional review board and agree to its provisions.
- •The patient has completed all preoperative investigations.
排除标准
- •Requires emergency surgery
- •Has acute myocardial infarction (MI) within 30 days prior to screening date
- •Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within six months prior to screening date
- •Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
- •Has active endocarditis/myocarditis or endocarditis/myocarditis within three months prior to screening date
- •Has renal insufficiency as determined by creatinine level ≥ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
- •Has documented:
- •leukopenia (WBC < 3.5x 103/µL),
- •acute anemia (Hgb<10.0 g/dL or 6 mmol/L), or
- •thrombocytopenia (platelet count < 50x 103/µL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior screening date
- •Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
- •Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation
- •RVOT aneurysm unless treated during pulmonary valve replacement surgery
- •Has prior organ transplant or is currently an organ transplant candidate
- •Was previously implanted with study trial device
- •Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve or mechanical valve
- •Has presence of non-cardiac disease limiting life expectancy to less than 12 months
- •Is currently or has recently participated (within six weeks) in another investigational drug or device trial
- •Positive urine or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers
- •Currently incarcerated or unable to give voluntary informed consent
- •Documented history of substance (drug or alcohol) abuse within the last five years prior to screening date
结局指标
主要结局
Freedom from death and reoperation
时间窗: 2 years after implantation
The primary safety endpoint for the trial is freedom from device or procedure related death and/or reoperation at 2 years after implantation.
次要结局
- Safety endpoints(2 years after implantation)
研究者
Erhan Urganci
MD
Medical University of Vienna