Evolut™ EXPAND TAVR II Pivotal 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
- 650
- 试验地点
- 186
- 主要终点
- Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
研究概览
简要总结
Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.
详细描述
Multi-center, international, prospective, randomized study. Subjects will be randomized to either transcatheter aortic valve replacement (TAVR) with the Evolut PRO+ TAVR System, or Evolut FX System, and guideline-directed management (GDMT) or GDMT alone.
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
- •o Moderate AS, defined as follows by transthoracic echo (TTE) as assessed by the ECL:
- •AVA >1.0 cm² and <1.5cm²; or
- •AVA ≤ 1.0 cm² with AVAI > 0.6cm²/m² if BMI < 30 kg/m²: or
- •AVA ≤ 1.0 cm² with AVAI > 0.5cm²/m² if BMI ≥ 30 kg/m²:
- •Max aortic velocity ≥ 3.0 m/sec. and < 4.0 m/sec. or
- •Mean aortic gradient ≥ 20mmHg and < 40.0 mmHg
- •Any of the following at-risk features:
- •Symptoms of AS, defined as:
- •NYHA ≥ Class II, or
- •Reduced functional capacity, defined as
- •6MWT < 300 meters, or
- •< 85% of age-sex predicted METs on exercise tolerance testing (ETT)
- •Documented heart failure event or hospitalization for heart failure within 1 calendar year prior to consent
- •NT-proBNP ≥ 600 pg/ml (or BNP ≥ 80 pg/ml), or
- •Persistent AF or Paroxysmal AF episode within 6 months prior to consent, or
- •Elevated aortic valve calcium score (>1200 AU for females and > 2000 AU for males) as assessed by the MDCT core lab, or
- •Any of the following by the qualifying TTE as assessed by the ECL:
- •Global longitudinal strain ≤16% (absolute value), or
- •E/e' ≥ 14.0 (average of medial and lateral velocities), or
- •Diastolic dysfunction ≥ Grade II, or
- •LVEF < 60%
- •Stroke Volume Index < 35 ml/m²
- •Anatomically suitable for transfemoral TAVR using the Medtronic Evolut PRO+ or Evolut FX system
- •The subject and the treating physician agree the subject will return for all required follow-up visits
排除标准
- •Age < 65 years
- •LVEF ≤ 20% by 2-D echo
- •Class I indication for cardiac surgery
- •Contraindication for placement of a bioprosthetic valve
- •Documented history of cardiac amyloidosis
研究组 & 干预措施
Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT)
Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, & guideline-directed management & therapy
干预措施: Medtronic Evolut PRO+ TAVR System, or Evolut FX TAVR System, and guideline-directed management and therapy (GDMT) (Device)
Clinical site determined guideline-directed management and therapy (GDMT) alone
Clinical site determined guideline-directed management and therapy (GDMT) alone
结局指标
主要结局
Composite rate of all-cause mortality, all-stroke, life threatening or fatal bleeding, acute kidney injury, hospitalization due to device or procedure-related complication, or valve dysfunction requiring reintervention.
时间窗: 30 days
Life threatening or fatal bleeding is defined as BARC Type 3 or 4 and acute kidney injury is defined as VARC-3 Stage IV.
Composite rate of all-cause mortality, heart failure hospitalization or event, or medical instability leading to aortic valve replacement or re-intervention.
时间窗: 2 years
次要结局
- Heart failure hospitalizations or events.(2 years)
- Composite of all-cause mortality and heart failure hospitalizations or events.(2 years)
- Days alive and free of unplanned cardiovascular hospitalizations(2 years)
- All-cause mortality(2 years)
- Unplanned cardiovascular hospitalizations(2 years)
- Proportion of subjects alive and with moderately improved quality of life (≥ 10 points in KCCQ summary score from baseline)(1 year)
- Composite of all-cause mortality, all-stroke, or unplanned CV hospitalizations(2 years)