Safety and Efficacy of the Symetis ACURATE Neo/TF Compared to the Edwards SAPIEN 3 Bioprosthesis for Transcatheter Aortic Valve Implantation by Transfemoral Approach.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 739
- 试验地点
- 40
- 主要终点
- Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is an established treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). Many novel devices are currently being developed and established transcatheter heart valves undergo design reiterations to address limitations and reduce complication rates associated with the device and implantation procedure. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves. The aim of this study is to assess non-inferiority of the self-expandable Symetis ACURATE neo/TF in comparison to the balloon-expandable Edwards SAPIEN 3 transcatheter aortic valve bioprosthesis with regard to early safety and clinical efficacy at 30 days.
详细描述
Background:
Transcatheter aortic valve implantation (TAVI) is an established and valuable treatment option for patients with severe symptomatic aortic stenosis and at increased risk for surgical aortic valve replacement (SAVR). The use of TAVI is rapidly expanding worldwide and the indications for TAVI are widening into lower risk populations in view of favorable outcomes among high and intermediate risk patients. Many novel devices are currently developed or established devices undergo design reiterations to address limitations, such as vascular access complications, paravalvular regurgitation, and atrio-ventricular conductance disturbances. However, device comparisons by use of randomized trials are scarce in particular for newer generation transcatheter valves.
The Symetis ACURATE neo/TF, a self-expandable transcatheter valve delivered via transfemoral access, gained Conformité Européenne (CE) marking in September 2014 after showing favorable procedural and short term results. The SCOPE I trial will compare its performance to the balloon-expandable Edwards SAPIEN 3, a widely used and well-established transcatheter heart valve of the second generation, in a randomized fashion.
Objectives:
The primary objective is the comparison of the Symetis ACURATE neo/TF to the Edwards SAPIEN 3 transcatheter aortic bioprosthesis with regard to early safety and clinical efficacy at 30 days. Secondary objectives involve the comparison between the two devices with regard to secondary clinical and echocardiographic endpoints at 30 days, 1 year and 3 years.
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
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with severe aortic stenosis defined by an aortic valve area (AVA) < 1cm2 or AVA indexed to body surface area (BSA) of < 0.6 cm2/m2, including low-flow severe aortic stenosis defined by stroke volume index (SVI) < 35ml/m2, as assessed by integration of echocardiographic and invasive measurements
- •Subject is symptomatic (heart failure symptoms with New York Heart Association (NYHA) Functional Class > I, angina or syncope)
- •Patient is considered at increased risk for mortality if undergoing conventional surgical aortic valve replacement or judged as not operable as determined either
- •by a Logistic EuroSCORE > 20 % OR
- •by a STS-PROM score > 10% OR
- •by the heart team consisting of at least one cardiologist and cardiac surgeon based on the integration of individual clinical and anatomical factors not captured by risk-scores, the patient's age, frailty and life-expectancy
- •The heart team agrees on eligibility of the patient for participation and that TAVI by transfemoral access constitutes the most appropriate treatment modality, from which the patient will likely benefit most
- •Aortic annulus dimensions suitable for both valve types (area range: 338-573 mm2 AND perimeter range: 66-85 mm) based on ECG-gated multislice computed tomographic measurements. Findings of transesophageal echocardiography (TEE) and conventional aortography should be integrated in the anatomic assessment if available
- •Arterial aorto-iliac-femoral axis suitable for transfemoral access with a minimum access vessel diameter ≥ 6 mm as assessed by multislice computed tomographic angiography and/or conventional angiography
- •Written informed consent of the patient or her/his legal representative
- •Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
排除标准
- •Non-valvular aortic stenosis
- •Congenital aortic stenosis or unicuspid or bicuspid aortic valve
- •Non-calcific acquired aortic stenosis
- •Anatomy not appropriate for transfemoral transcatheter aortic valve implantation due to size of the aortic annulus or degree or eccentricity of calcification of the native aortic valve or tortuosity of the aorta or ilio-femoral arteries
- •Emergency procedure including patients in cardiogenic shock (low cardiac output, vasopressor dependence, mechanical hemodynamic support)
- •Severely reduced left ventricular (LV) function (ejection fraction < 20%)
- •Pre-existing prosthetic heart valve in aortic position
- •Presence of mitral valve prosthesis
- •Concomitant planned procedure except for percutaneous coronary intervention (PCI)
- •Planned non-cardiac surgery within 30 days
- •Stroke within 30 days of the procedure.
- •Myocardial infarction within 30 days of the procedure (except type 2)
- •Evidence of intra-cardiac mass, thrombus or vegetation
- •Severe coagulation conditions
- •Inability to tolerate anticoagulation/anti-platelet therapy
- •Active bacterial endocarditis or other active infections
- •Hypertrophic cardiomyopathy with or without obstruction
- •Contraindication to contrast media or allergy to nitinol
- •Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
结局指标
主要结局
Modified* combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
时间窗: 30 days
(\* "NYHA class III or IV" is omitted due to lack of objectiveness in its ascertainment) * All-cause mortality * All stroke (disabling and non-disabling) * Life-threatening or disabling bleeding * Acute kidney injury (stage 2 or 3, including renal replacement therapy) * Coronary artery obstruction requiring intervention * Major vascular complication * Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention) * Rehospitalization for valve-related symptoms or worsening congestive heart failure * Valve-related dysfunction: prosthetic aortic valve stenosis (mean gradient ≥ 20 mmHg, effective orifice area ≤ 0.9-1.1cm2 and/or Doppler velocity index \< 0.35) AND/OR ≥ moderate prosthetic valve regurgitation)
次要结局
- Device success(30 days)
- Early safety(30 days)
- Annular rupture(procedural)
- Clinical efficacy(30 days)
- All stroke (disabling and non-disabling)(30 days, 1 year, 3 years)
- Acute kidney injury (stage 2 or 3, including renal replacement therapy)(30 days, 1 year, 3 years)
- All-cause mortality(30 days, 1 year, 3 years)
- Mean trans-prosthetic aortic gradient(30 days, 1 year, 3 years)
- Time-related valve safety(30 days, 1 year)
- New pacemaker implantation(30 days, 1 year, 3 years)
- Valve thrombosis(30 days, 1 year, 3 years)
- Life-threatening or disabling bleeding(30 days, 1 year, 3 years)
- Coronary artery obstruction requiring intervention(30 days, 1 year, 3 years)
- Valve-related dysfunction: prosthetic aortic valve stenosis AND/OR ≥ moderate prosthetic valve regurgitation(30 days, 1 year, 3 years)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 score(30 days, 1 year, 3 years)
- Major vascular complication(30 days, 1 year, 3 years)
- Valve related dysfunction requiring repeat procedure (balloon aortic valvuloplasty, TAVI or SAVR in a separate intervention)(30 days, 1 year, 3 years)
- Conversion to open heart surgery(procedural)
- Rehospitalization for valve-related symptoms or worsening congestive heart failure(30 days, 1 year, 3 years)
- Aortic regurgitation(30 days, 1 year, 3 years)