NL-OMON56063招募中不适用
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid* TMVR Transfemoral System in patients with severe symptomatic mitral regurgitation - APOLLO-EU Trial - APOLLO-EU trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
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
- •- Subject has moderate-to-severe or severe symptomatic mitral regurgitation as
- •defined by the American Society of Echocardiography 2017 Guidelines and
- •Standards - Recommendations for Non-invasive Evaluation of Native Valvular
- •Regurgitation,or subject has moderate symptomatic mitral regurgitation combined
- •with mitral stenosis with the presence of MAC
- •- Local site multidisciplinary heart team experienced in mitral valve therapies
- •agrees that patient is unsuitable for treatment with approved transcatheter
- •repair or conventional mitral valve surgery
- •- Subject and the treating physician agree that the subject will return for all
- •required post-procedure follow-up visits
- •- Subject meets the legal minimum age to provide informed consent based on
- •local regulatory requirements
- •- Subjects anatomically suitable for the Medtronic Intrepid* TMVR TF System
排除标准
- •- Estimated life expectancy of less than 24 months
- •- Currently surgically implanted mitral valve
- •- Prior transcatheter mitral valve procedure with device currently implanted
- •- Anatomic contraindications
- •- Anatomically prohibitive mitral annular calcification (MAC)
- •- Aortic valve disease requiring intervention or previous intervention within
- •90 days of enrollment
- •- LVEF < 25% (measured by resting transthoracic echocardiogram).
- •- Left ventricular end diastolic diameter (LVEDD) > 75mm
- •- Need for emergent or urgent surgery
- •- Hemodynamic instability
- •- History of bleeding diathesis or coagulopathy
- •- End stage renal disease
- •- Liver failure
研究者
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