NL-OMON45353尚未招募不适用
SAFETY AND PERFORMANCE OF THE TRIALIGN PERCUTANEOUS TRICUSPID VALVE ANNULOPLASTY SYSTEM (PTVAS) FOR SYMPTOMATIC CHRONIC FUNCTIONAL TRICUSPID REGURGITATION - SCOUT-II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
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
- •1. >=18 and <=85 years old
- •2. New York Heart Association (NYHA) Class II, III or ambulatory IV
- •3. Symptomatic despite Guideline Directed Medical Therapy (GDMT) for at least 1 month; including diuretics
- •4. The patient is at high risk for open heart valve surgery
- •5. The heart team recommends tricuspid annuloplasty, in accordance with the recommendations of the 2012 ESC Valve Guidelines
- •6. Patient or legal guardian understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
- •7. Patient is willing and able to comply with all specified study evaluations
排除标准
- •1. History of heart transplant
- •2. Severe uncontrolled hypertension (SBP >= 180 mmHg and/or DBP >= 110 mmHg)
- •3. Previous tricuspid valve repair or replacement (including artificial valve)
- •4. Presence of LVAD, trans-tricuspid pacemaker or defibrillator leads
- •5. Active endocarditis
- •6. Severe coronary artery disease
研究者
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