NCT04443023已完成不适用
Randomized Comparison of Eligible TAVI-valves - Cohort B (Sapien Versus Myval)
Aarhus University Hospital Skejby1 个研究点 分布在 1 个国家目标入组 1,031 人开始时间: 2020年6月15日最近更新:
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
- 1,031
- 试验地点
- 1
- 主要终点
- Percentage of patients with MACE (Major Adverse Cardiovascular Events)
研究概览
简要总结
The study performs head-to-head comparison of two TAVI-valves: Sapien and Myval.
详细描述
The purpose of the present study is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose: To randomize between two TAVI-valve types in patients who according to a heart team conference is found eligible for treatment with more than one valve.
Hypotheses:
- There is no difference in the combined endpoint (death, stroke, moderate/severe para-valvular leakage, moderate/severe device stenosis) between the two valves to be compared.
- There is no difference between valves in secondary endpoints: death, stroke, moderate/major paravalvular leakage, moderate/severe aortic device stenosis, new pacemaker implantation, readmission for congestive heart failure, 6-minute walk test, and degeneration of the valve as evaluated by computerized tomography (HCT), transthoracic echocardiography (TTE), transesophageal echocardiography (TEE), or MRI.
Design: Randomized controlled trial with clinical national registry follow-up.
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
- •Patient more than 18 years of age.
- •Patient eligible for at least 2 valves being implanted routinely at the participating center, according to a TAVI heart team conference.
- •The center experience for each of the valves considered should be more than 15 cases a year, and at least 15 valves implanted before a valve can be used in the trial.
- •The center volume should be more than 75 cases a year.
- •The patient has given signed informed consent.
- •TAVI performed via the femoral artery.
排除标准
- •1. Not able to give written inform consent
研究组 & 干预措施
Sapien
Active Comparator
Patients randomized to treatment
干预措施: chosen TAVI valve (Device)
Myval
Active Comparator
Patients randomized to treatment
干预措施: chosen TAVI valve (Device)
结局指标
主要结局
Percentage of patients with MACE (Major Adverse Cardiovascular Events)
时间窗: 1 year
Mortality, stroke, moderate/major PVL, moderate/severe aortic device stenosis at 1 year, using VARC-3 criteria
次要结局
- Percentage of patients with other TAVI-related complications(During TAVI-procedure)
- Other tavi-related complications(30-day)
- Percentage of patients with new pacemaker(During admission, 30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with prosthesis-patient mismatch(30-day, 1-year, 3-year, 5-year, 10-year)
- Mean effective orifice area measured by MRI(30-day)
- Percentage of patients with stroke(During admission, 30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with endocarditis(30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with major vascular access site and access-related complications(During admission and 30-day)
- Percentage of patients with MACE(30 day, 3-year, 5-year and 10-year)
- Percentage death(30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with moderate/major aortic stenosis(30-day, 1-year, 3-year, 5-year, 10-year)
- Proportion with successful implantation of the chosen valve.(During procedure)
- Percentage of patients with moderate/severe PVL stratified according to level of annular calcium on HCT in three groups(30-day)
- Mean Gradient (AO) stratified according to level of annular calcium on HCT in three groups(30-day)
- AMI(30-day, 1-year, 3-year, 5-year and 10-year)
- PCI og CABG(30-day, 1-year, 3-year, 5-year and 10-year)
- Reopeation(30-day, 1-year, 3-year, 5-year and 10-year)
- Percentage of patients with moderate or severe paravalvular leakage(30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with major bleeding(30-day, 1-year, 3-year, 5-year, 10-year)
- Distance in meters during 6-minute walk test(30-day, 1-year, 3-year, 5-year, 10-year)
- Percentage of patients with valve thrombosis or severe stenosis(30-day, 1-year, 3-year, 5-year, 10-year)
- Mean volume of aortic regurgitation measured by MRI(30-day)
- Percentage of patients with readmission with congestive heart failure(30-day, 1-year, 3-year, 5-year, 10-year)
- Afib(30-day, 1-year, 3-year, 5-year and 10-year.)
- Percentage of patients with increase in creatinin level of 100% or more, or dialysis(during admission and within 30 days)
- Percentage of patients with leaflet thickening (hypoattenuated leaflet thickening = HALT) or reduced leaflet motion or thrombus assessed by HCT(30-day and 1-year)
研究者
Christian Juhl Terkelsen
Principal investigator
Aarhus University Hospital Skejby
研究点 (1)
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