Randomized Comparison of Evolut FX Versus Sapien 3 Ultra Resilia. The Compare-TAVI 2 Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,370
- 试验地点
- 3
- 主要终点
- Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration
研究概览
简要总结
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
详细描述
The purpose of the "Compare-TAVI" organization is to ensure a continuous comparison of the TAVI-valves implanted, and to monitor long-term valve performances.
Purpose of present study:
To compare outcome in patients randomized to treatment with Evolut FX versus Sapien 3 Ultra Resilia.
Hypotheses:
- Evolut FX is non-inferior to Edwards Sapien 3 Resilia with regard to the combined endpoint (death, stroke, moderate/severe aortic regurgitation, moderate/severe valve deterioration) between the two valves being compared.
- There is no difference between valves in secondary safety and efficacy endpoints (see below)
- There is no difference in Aortic Regurgitation fraction (ARF) and Effective Orifice Area (EOA) measured by CMR (CMR-substudy, N=166)
- There is no difference in EOA measured invasively during dobutamine stress (hemodynamic substudy, N=440).
- There is no difference in occurrence of Hypoathenuated Leaflet Thickening (HALT) measured by CT (CT-substudy, N=778).
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
盲法说明
The patient and operator cannot be blinded to allocated treatment. Most outcomes are registry based and randomization is not anticipated to impact outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient more than 18 years of age.
- •Patient eligible for both Evolut FX and Edwards Sapien 3 Ultra Resilia 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 the treating physician should have implanted at least 15 of each valve 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
- 未提供
研究组 & 干预措施
Medtronic Evolut FX
TAVI procedure performed with Medtronic Evolut FX
干预措施: Medtronic Evolut FX (Device)
Edwards Sapien Ultra 3 Resilia
TAVI procedure performed with Edwards Sapien Ultra 3 Resilia
干预措施: Edwards Sapien 3 Ultra Resilia (Device)
结局指标
主要结局
Mortality, stroke, moderate/major aortic regurgitation, moderate/severe THV deterioration
时间窗: 1-year, 3-year, 5-year, 10-year
The primary composite endpoint is at one-year, and a non-inferiority test is performed. See separate statistical analysis plan. Separate analyses of each component of the primary outcome will be presented, in accordance with the FDA guidelines and EMA guidelines, i.e. mortality, stroke, moderate/severe aortic regurgitation and moderate/severe THV deterioration to better understand their contribution to the primary endpoint. If non-inferiority is proven for the primary composite endpoint, a split alfa is used to test for superiority if possible (alfa=0.025) and to test secondary safety and efficacy endpoints (Total alfa=0.025 for these). The composite endpoint will be re-analyzed after 3-, 5- and 10-year as superiority analyses.
次要结局
- TAVI-related complications(7-days)
- Proportion with successful implantation of the chosen valve.(7-days)
- SMART criteria for bioprosthetic valve dysfunction through 12 months(1-year)
- Pacemaker-implantation(1-year)
- Vascular and access-related complications (exploratory only)(30-days)
- Bleeding and transfusion (exploratory only)(30-days)
- Endocarditis (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year)
- Reoperation (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year)
- Moderate/severe prosthesis-patient mismatch (exploratory only)(30-day)
- Mean gradient (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year)
- Pacemaker-implantation (exploratory only)(30-day prior to TAVI, 30-day, 1-year, 3-year, 5-year, 10-year)
- Readmission for congestive heart failure (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year.)
- Kidney injury (exploratory only)(30-day)
- AMI (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year.)
- Revascularization (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year.)
- Atrial fibrillation (exploratory only)(30-day, 1-year, 3-year, 5-year, 10-year.)
研究者
Christian Juhl Terkelsen
Professor, MD, DmSc, PhD
Aarhus University Hospital Skejby