A Randomized Comparison of the EDWARDS INTUITY Valve System anD commErcially Available Aortic Bioprostheses in Subjects uNdergoing surgiCal Aortic Valve replacEment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Average Amount of Time Subject Spent on Cardiopulmonary Bypass
研究概览
简要总结
The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.
详细描述
This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.
Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic 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
- •≥18 years of age
- •aortic stenosis / mixed aortic stenosis and aortic insufficiency
- •SAVR+CABG (1-4 distal anastomoses)
- •Log. EuroSCORE ≥6
- •NYHA Class ≥II
- •Exclusion (i.a.):
- •pure aortic insufficiency
- •pre-existing prosthetic heart valve or ring
- •congenital true bicuspid / unicuspid aortic valve
- •LVEF <20%
排除标准
- 未提供
研究组 & 干预措施
EDWARDS INTUITY
EDWARDS INTUITY Valve System, Model 8300A
干预措施: EDWARDS INTUITY (Device)
Stented aortic bioprostheses
Stented aortic bioprostheses
干预措施: Stented aortic bioprostheses (Device)
结局指标
主要结局
Average Amount of Time Subject Spent on Cardiopulmonary Bypass
时间窗: At time of surgery, an average of 2 hours
Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.
Average Subject Time Spent on Cardiopulmonary Cross Clamp
时间窗: At time of surgery, an average of 1.5 hours
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.
次要结局
- Subjects Who Experienced Major Bleeding Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Conversion of Edwards INTUITY Surgical Aortic Valve to Control During Surgery.(Prior to Surgery)
- Subjects Who Received a Permanent Pacemaker Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Average Mean Gradients (mmHg) Measurements Over Time.(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Effective Orifice Area Index (EOAI) Measurement Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects Who Required a Thoracic Resternotomy Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With Endocarditis Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Thromboembolism Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects Who Died Intraoperatively(Surgery)
- Subject's Effective Orifice Area (EOA) Measurement Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With a Major Paravalvular Leak (OPC) Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Cerebral Vascular Accident or Permanent Stroke Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Cardiac Tamponade Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Amount of Aortic Valvular Regurgitation Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With Renal Failure Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects With a Myocardial Infarction Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Number of Participants With Change From Baseline in New York Heart Association (NYHA) Class at 2 Years.(Baseline and 2 Years)
- Subject's Average Peak Gradients (mmHg) Measurements Over Time.(30 days, 3 months, 6 months, 1 year, 2 year)
- Subjects With a Cardiac Reoperation for Any Reason Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Average Score SF-12 - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subjects Who Experienced Respiratory Failure Over Time(30 days, 3 Months , 6 Months, 1 Year, 2 Years.)
- Subjects With a Deep Sternal Would Infection Over Time(30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)
- Health Care Utilization(Day of surgical procedure through discharge from the hospital, an average of 2 weeks)
- Subject's Average Score on the KCCQ - Quality of Life Questionnaire Over Time(Baseline, 30 days, 3 Months, 6 Months, 1 Year, 2 Years.)