NCT02656290已完成不适用
Prospective, Non-Randomized, Single Arm, Multicenter Clinical Evaluation of the Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement
Edwards Lifesciences2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
研究概览
简要总结
The objective of this trial is to assess the safety and effectiveness of the Edwards Pericardial Aortic Bioprosthesis Model 11000A, in the pulmonary position in pediatric and adult subjects five years or older requiring replacement of their native or prosthetic pulmonary valve.
详细描述
This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100) pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled. Clinical data will be collected from at least 3 centers with data available on patients who have completed the 1 year follow-up visit. Subjects will be followed for and assessed after implant for up to 5 years.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has pulmonary valve disease requiring pulmonary valve replacement of their native or prosthetic valve
- •Is greater than or equal to 5 years of age
- •Subject and/or subject's legal representative has provided written informed consent as approved and required by the respective institutional review board and agrees to its provisions. NOTE: Written consent must be obtained prior to any research related test being performed.
排除标准
- •A subject meeting any of the following criteria shall be excluded:
- •Valve-in-conduit procedure
- •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 6 months (180 days) 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 3 months prior to screening date
- •Has renal insufficiency as determined by creatinine (S-Cr) level ~ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
- •Has documented leukopenia (WBC < 3.5x 103/I-lL), acute anemia (Hgb <10.0 g/dL or 6 mmol/L), or thrombocytopenia (platelet count < 50xl03/I-lL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior to 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 INSPIRIS RESILIA Pulmonary valve
- •Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve, mechanical valve, or annuloplasty ring
- •Need for concomitant replacement of the aortic, mitral or tricuspid valves
- •Has presence of non-cardiac disease limiting life expectancy to less than 12 months
- •Is Currently or has recently participated (within 6 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, or planning to become pregnant within 1 year of study valve implant
- •Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior to screening date
- •Currently incarcerated or unable to give voluntary informed consent
- •Documented history of substance (drug or alcohol) abuse within the last 5 years prior to screening date
- •Patients with hypersensitivity to metal alloys that contain cobalt, chromium, nickel, molybdenum, manganese, carbon, beryllium and iron
- •Patients with hypersensitivity to latex
- •Intra-Op Exclusion Criterion:
- •Significant injury to the heart upon entry defined as emergent cardiopulmonary bypass requiring femoral cannulation
结局指标
主要结局
Percentage of Subject's With Freedom From Device or Procedure Related Death and/or Reoperation at 1-year Post-implant.
时间窗: 1-year post-implant
Subject's freedom from device or procedure related death and/or reoperation at 1-year post-implant. Time to events were estimated by Kaplan-Meier method. A higher number means a better outcome.
次要结局
- Percentage of Early Adverse Events(Percentage of events occurring within 30 days of procedure)
- Subject's Average Mean Gradient Measurements Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Amount of Paravalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size(Discharge, 30 days, 3 months, and annually thereafter for up to 5 years)
- Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) for the Trial Valve Cohort.(Events occurring ≥ 31 days and up through 5 years post implant.)
- Subject's Average Peak Gradient Measurements Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Subject's Average Doppler Velocity Index (DVI)(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Change in Subject's New York Heart Association (NYHA)/Modified Ross Heart Failure Functional Class(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Subject's Average Tricuspid Regurgitation (TR) Gradient Measurement Over Time.(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Subject's Average Peak Velocity Measurement Over Time(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Subject's Average Transvalvular Velocity Time Interval (VTI)(Baseline, 30 days, 3 months, and annually thereafter for up to 5 years)
- Amount of Transvalvular Pulmonary Regurgitation in Subjects Over Time by Valve Size(Discharge, 30 days, 3 months, and annually thereafter for up to 5 years)
研究者
研究点 (2)
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