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临床试验/NCT02672553
NCT02672553已完成不适用

A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve Replacement Using Minimally InvaSive Techniques

Edwards Lifesciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年5月1日最近更新:
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适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Median Subject Time Spent on Cardiopulmonary Cross Clamp
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.

详细描述

This is a randomized study to compare the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system in a minimally invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach, in patients with logistic EuroScore < 20 undergoing elective isolated aortic valve replacement (AVR) surgery.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and to explore additional healthcare resource utilization endpoints.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •adult male or female ≥18 years of age
  • •symptomatic for aortic stenosis / mixed aortic stenosis and aortic insufficiency disease for which isolated surgical aortic valve replacement without concomitant procedures is planned
  • •EuroSCORE <20
  • •NYHA Class ≥II
  • •Subject has signed and dated the investigation informed consent form prior to study specific procedures are performed
  • •Subject is geographically stable and agrees to participate in follow-up assessments as specified in the protocol and informed consent
  • •Exclusion (i.a.):
  • •pure aortic insufficiency
  • •previous cardiac surgery (involved FS or MIS approach)
  • •congenital true bicuspid / unicuspid aortic valve
  • •requires emergency surgery or has had emergency surgery for any reason
  • •≤ 1 month before the intended treatment
  • •active endocarditis ≤ 6 months before the intended treatment
  • •acute MI ≤ 90 days before the intended treatment
  • •had a stroke or transient ischemic attack within six months prior to scheduled aortic valve replacement surgery
  • •oxygen or ventilator dependent
  • •life expectancy < 12 months
  • •substance abuser
  • •Female subject is pregnant or lactating
  • •documented leukopenia (WBC < 3.5x 103/μL), acute anemia (Hgb < 10.0 gm/dL or < 6.2 mmol/L), thrombocytopenia (platelet count < 100x 103/mL), or history of bleeding diathesis or coagulopathy
  • •hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days of procedure
  • •documented echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • •renal insufficiency as determined by Serum creatinine ≥ 200 μmol/L (2.27 mg/dL) at screening or end-stage renal disease requiring chronic dialysis
  • •documented hyperparathyroidism
  • •currently participating in an investigational drug or device trial for which follow-up has not yet been completed
  • •Minimally Invasive access to the heart is not possible due to anatomical constraints or any other pre-existing condition
  • •Intra-operative

排除标准

  • •has calcium on the anterior mitral leaflet which cannot be removed
  • •has extensive calcification of the aortic root
  • •Annular deformation which may or may not be caused by too extensive decalcification of the aortic annulus
  • •has left atrial thrombus
  • •The position of the coronary ostia relative to the EDWARDS INTUITY Valve would result in obstruction of blood flow
  • •hemodynamically unstable during the procedure requiring the procedure to be aborted prior to insertion of the study bioprosthesis and delivery system
  • •Study device is not available in the correct size for the subject

研究组 & 干预措施

EDWARDS INTUITY

Active Comparator

EDWARDS INTUITY Valve System, Model 8300A

干预措施: EDWARDS INTUITY Valve System, Model 8300A (Device)

Stented Aortic Bioprostheses

Active Comparator

Stented Aortic Bioprostheses

干预措施: Stented Aortic Bioprostheses (Device)

结局指标

主要结局

Median Subject Time Spent on Cardiopulmonary Cross Clamp

时间窗: At time of surgery; an average of 1 hour

Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

Median Amount of Time Subject Spent on Cardiopulmonary Bypass

时间窗: At time of surgery; an average of 1 hour

Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

次要结局

  • Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.(Baseline and 2 Years.)
  • Subject's Average Mean Gradients (mmHg) Measurements Over Time.(Baseline, Discharge, 30 days, 3 Months, 1 Year)
  • Subject's Average Peak Gradients (mmHg) Measurements Over Time.(Baseline, Discharge, 30 days, 3 Months, 1 Year)
  • Subject's Effective Orifice Area (EOA) Measurement Over Time.(Baseline, Discharge, 30 days, 3 Months, 1 Year)
  • Amount of Paravalvular Leak Over Time.(Discharge, 30 days, 3 month, 1 year)
  • Conversion of Edwards INTUITY Surgical Aortic Valve to Control Surgical Aortic Heart Valves During Surgery.(Prior to Surgery)
  • Subjects Who Required a Thoracic Resternotomy Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects Who Received a Permanent Pacemaker Over Time.(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With Renal Failure Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With Endocarditis Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Deep Sternal Would Infection Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Myocardial Infarction Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Thromboembolism Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Cardiac Tamponade Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects With a Cardiac Reoperation for Any Reason Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Conversion of Subjects Undergoing Minimally Invasive Surgical Incision to Full Sternotomy for the Randomized to Edwards INTUITY Group During Surgery.(Prior to Surgery)
  • Subject's Average Score on the EQ-5D - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 1 Year)
  • Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 1 Year)
  • Subjects With a Paravalvular Leak > or Equal to 3+ and/or Requiring Intervention Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects Who Experienced Major Bleeding Over Time.(30 days, 3 Months, 1 Year, 2 Years.)
  • Subjects Who Experienced Respiratory Failure Over Time(30 days, 3 Months, 1 Year, 2 Years.)
  • Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 1 Year)
  • Health Care Utilization(Day of surgical procedure through discharge from the hospital, an average of 1.5 weeks)
  • Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.(Baseline, Discharge, 30 days, 3 Months, 1 Year)
  • Amount of Aortic Valvular Regurgitation Over Time.(Discharge, 30 days, 3 month, 1 year)

研究者

发起方
Edwards Lifesciences
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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