Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly Patients With Severe Aortic Stenosis and Small Aortic Annuli: A Prospective Randomized Study The VIVA 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
- 300
- 试验地点
- 2
- 主要终点
- Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)
研究概览
简要总结
To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.
详细描述
This is a prospective, multicenter, randomized open-label trial including patients with severe AS and small aortic annulus (mean aortic annuli diameter ˂23mm and minimal diameter ≤21.5mm, evaluated by 3D-CT or 3D-TEE). Patients will be randomized in a 1:1 fashion to either TAVR or SAVR. The TAVR procedure will be performed with the ACURATE neo Aortic Valve, the Edwards SAPIEN 3 valve (20, 23 or 26mm) or the CoreValve Evolut R or Evolut PRO valve system (23 or 26 mm).New iterations of these valve models may also be included. The SAVR procedure will be performed using standard techniques, with no limitation in terms of type and size of the valve prosthesis or surgical procedure (e.g. enlargement of the aortic root). For both TAVR and SAVR, the choice of the type and size of valve, access route (for TAVR), utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the site treating the patient.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥65 years-old diagnosed with severe AS (defined as: jet velocity ≥ 4.0 m/s or mean gradient ≥ 40 mmHg or velocity ratio <0.25 AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2; OR mean gradient >30 mmHg AND aortic valve area ≤ 1.0 cm2 or aortic valve area index ≤ 0.6 cm2/m2 AND >1200 Agatston units for women or >2000 Agatston units for men as determined by non-contrast CT).
- •Small aortic annulus defined as a mean aortic annulus diameters ˂23 mm and a minimal aortic annulus diameter of ≤21.5 mm as measured by 3D-computed tomography (CT) and/or 3D-transesophageal echocardiography (TEE).
排除标准
- •Prohibitive surgical risk as determined by the Heart Team
- •Porcelain aorta
- •Aortic root dilatation >45 mm
- •Coronary artery disease (CAD) not treatable by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), or SYNTAX score >32 (in the absence of prior revascularization) or severe left main disease
- •Non-calcific aortic stenosis
- •Severe mitral regurgitation
- •Moderate-to-severe tricuspid regurgitation requiring surgical repair
- •Prior surgical valve in aortic position
结局指标
主要结局
Valve performance: rate of prothesis-patient mismatch (PPM) and/or aortic regurgitation (AR)
时间窗: 60 days
Severe PPM \[defined as an indexed aortic valve area ≤0.65 cm2/m2 \] and/or ≥moderate AR \[Valve Academic Research Consortium-2 (VARC-2) definition\].
次要结局
- Cardiac re-hospitalization(30 days, 1 year and 5 years)
- Rate of AR(60 days, 1 year and 5 years)
- Mortality(30 days, 1 year and 5 years)
- Exercise capacity(60 days, 1 year and 5 years)
- Combined Safety endpoint(30 days, 1 year and 5 years)
- Quality of life(30 days, 60 days, 1 year and 5 years)
- Stroke(30 days, 1 year and 5 years)
- Rate of PPM(60 days, 1 year and 5 years)
- Transvalvular gradient(60 days, 1 year and 5 years)
- Bleeding(30 days, 1 year and 5 years)
- Rate of new atrial fibrillation(30 days, 1 year and 5 years)
- Day of hospital stay(For the duration of hospital stay)
- Combined endpoints: rate of AR or PPM(1 year and 5 years)
- Combined endpoints: LVEF and LV(60 days, 1 year and 5 years)
研究者
Josep Rodes-Cabau
MD
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec