NL-OMON55148撤回不适用
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex* Performer - The Leaflex* Standalone Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •1. Male and female age >18 years.
- •2. Patient with severe aortic stenosis.
- •3. Senile degenerative severe aortic valve stenosis with echocardiography
- •derived criteria: mean gradient > 40 mmHg OR jet velocity > 4.0 m/s OR AVA *
- •1.0 cm2 OR AVA index (AVAi) * 0.6 cm2/m2.
- •4. NYHA Functional Class * 2 OR exercise test that demonstrates a limited
- •exercise capacity, abnormal BP response, or arrhythmia.
- •5. Not recommended by the heart team for immediate treatment with surgical or
- •transcatheter aortic valve replacement.
排除标准
- •1. Aortic valve is unicuspid, bicuspid, or non-calcified.
- •2. Severe aortic regurgitation (>2+).
- •3. An exceptional aortic valve leaflet Calcium morphology, as determined by the
- •CT Core Lab.
- •4. Pre-existing mechanical or bioprosthetic aortic or mitral valve.
- •5. Iliofemoral vessel characteristics that would preclude safe placement of the
- •introducer sheath.
- •6. Coronary disease that, in the opinion of the heart team, should be treated;
- •or treatment of coronary disease * 1 month prior to index procedure.
- •7. Aortic balloon valvuloplasty * 3 months prior to index procedure.
- •8. CVA or TIA * 12 months prior to index procedure.
- •9. History of a myocardial infarction (MI) * 6 weeks prior to index procedure.
- •10. Previous or current bacterial endocarditis.
- •11. Ongoing severe infection or sepsis.
- •12. Life expectancy * 12 months post index procedure due to morbidity other
- •than aortic valve related.
研究者
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