NL-OMON50124招募中不适用
Expanded Clinical Study of Tendyne Mitral Valve System - Tendyne Study CS-03
Tendyne Holdings, Inc0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
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 64（—）
入选标准
- •Subjects must meet ALL of the following criteria:
- •1. Severe mitral regurgitation of primary or secondary etiology.
- •2. New York Heart Association (NYHA) functional Class >= II. If Class IV,
- •patient must be ambulatory.
- •3. Heart team determines patient is not a suitable candidate for traditional
- •surgical treatment.
- •4. Age 18 years or older.
排除标准
- •Subjects will be excluded if any of the following criteria are met:
- •1. Severe mitral annular calcification, severe mitral stenosis, valvular
- •vegetation or mass.
- •2. Left Ventricle (LV) or Left Atrium (LA) thrombus.
- •4. Left ventricular ejection fraction (LVEF) less than 30% by echocardiogram.
- •5. Left Ventricular End Diastolic Diameter (LVEDD) > 7.0 cm.
- •6. Prior surgical or interventional treatment of mitral or aortic valves
- •9. Myocardial Infarction (MI) within 30 days of the planned implant procedure.
- •10. Symptomatic, unresolved multi-vessel or unprotected left main coronary
- •artery disease requiring stenting or Coronary Artery Bypass Grafting (CABG).
- •12. Unresolved severe symptomatic carotid stenosis (> 70% by ultrasound).
- •14. Severe tricuspid regurgitation or severe right ventricular dysfunction.
- •15. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or
- •any other structural heart disease causing heart failure other than dilated
- •cardiomyopathy of either ischemic or non-ischemic etiology.
- •17. History of endocarditis within six months of planned implant procedure.
- •21. Patient has pulmonary arterial hypertension (fixed PAS >70mmHg).
研究者
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