JPRN-jRCT2032220015招募中3 期
Evolut EXPAND TAVR II Pivotal Trial
Shiotani Takuya0 个研究点目标入组 650 人开始时间: 2022年4月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 75age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Moderate AS, defined as follows by transthoracic ech - (TTE) at rest:
- •- Max aortic velocity >= 3.0 m/sec and < 4.0 m/sec, and
- •- Mean aortic gradient >= 20.0 mmHg and < 40.0 mmHg, and
- •- AVA >1.0 cm2 and < 1.5 cm2
- •- NYHA class >= II and symptoms of AS, including but not limited to:
- •- Dyspnea at rest or on exertion
- •- Syncope in the absence of another identifiable cause
- •- LVEF > 20% by 2-D ech -
- •- Any of the following
- •- HF event or hospitalization within 1 calendar year prior t - qualifying ech -
- •- NT proBNP >= 600 pg/ml (or BNP 80 pg/ml) measured within 6 months prior t - or within 2 weeks after qualifying echo,
- •- Global longitudinal strain =<15.0% (absolute value) at qualifying echo, or
- •- E/e (average of medial and lateral velocities) >= 14.0 at qualifying echo
排除标准
- •- Age < 65 years
- •- Class I indication for cardiac surgery
- •- Sievers Type 0 or Type 2 bicuspid aortic valve or Sievers Type 1 bicuspid aortic valve with ascending aorta diameter > 4.5 cm
- •- Not anatomically suitable for transfemoral TAVR
- •- In need of and suitable for coronary revascularization per Heart Valve Team
- •- Documented history of cardiac amyloidosis
研究者
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