NL-OMON55284招募中不适用
STRESS AORTIC VALVE INDEX FOR ASSESSING RISK IN AORTIC VALVE STENOSIS PATIENTS - SAVI-AoS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 50 years
- •2. Moderate aortic stenosis confirmed in the past 3 months by standard
- •echocardiographic evaluation: aortic valve area >1.0 cm2 plus either maximal
- •velocity 2.5-3.9 m/s or mean gradient 15-39 mmHg
- •3. Ability to undergo exercise stress testing
- •4. Ability to understand and the willingness to provide written informed
排除标准
- •1. Severe aortic stenosis
- •2. Percutaneous coronary intervention or coronary artery bypass grafting in the
- •past three months, or have revascularization planned in the near future
- •3. Known, unrevascularized, and severe coronary artery disease (for example a
- •90% diameter stenosis or FFR<0.7 in the proximal left anterior descending
- •4. Impaired left ventricular function (ejection fraction <50%)
- •5. Unicuspid, bicuspid, or non-calcified aortic valve observed during
- •echocardiography (note that later cusp fusion noted during study-related
- •cardiac imaging will not exclude a subject)
- •6. Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation,
- •or a significant intracardiac shunt
- •7. Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm
- •8. Persistent atrial fibrillation with uncontrolled ventricular response
- •9. Recent (within 6 weeks) acute coronary syndrome
- •10. Estimated glomerular filtration rate <=30 mL/min or end-stage renal disease
- •on replacement therapy (dialysis)
- •11. Severe COPD GOLD stage 3 or 4, home oxygen dependence, or >=2 pulmonary
- •inhalers (note that well-treated and stable asthma and GOLD stage 1 or 2 COPD
- •is permitted)
- •12. Severe comorbid condition with life expectancy <2 years
- •13. Prior adverse reaction to dobutamine
- •14. Severe iodine contrast allergy
- •15. Pregnancy
- •16. Severe pulmonary hypertension with systolic pulmonary artery pressure
- •greater than 50mmHg or isolated and symptomatic right ventricular failure
研究者
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