Stress Aortic Valve Index for normal aortic valves - SAVI-NORM

Catharina-ziekenhuis0 个研究点目标入组 8 人开始时间: 待定最近更新: 2024年4月15日

试验速览

暂无简介。

•- Age >= 18 years
•- No important aortic stenosis (AVA > 1.5 cm2, MAG < 20 mmHg, AOV max <= 2.5
•m/s) (note: high flow, high gradient is permitted if dimensionless index is
•- Normal LVEF (>= 50%)
•- Ability to undergo (exercise) stress testing
•- Ability to understand and the willingness to provide written informed consent

•- Any hemodynamic criterion for moderate or greater AS
•- Known, unrevascularized, and severe coronary artery disease (for example a
•90% diameter stenosis or FFR<0.7 in the proximal left anterior descending
•artery) (note: concurrent coronary artery percutaneous coronary intervention is
•- Impaired left ventricular function (ejection fraction <50%)
•- Unicuspid and bicuspid observed during echocardiography (note that later cusp
•fusion noted during study-related cardiac imaging will not exclude a subject)
•- Severe aortic regurgitation, mitral valve disease, tricuspid regurgitation,
•or a significant intracardiac shunt
•- Co-existing hypertrophic cardiomyopathy or severe septal hypertrophy >15mm
•- Persistent atrial fibrillation with uncontrolled ventricular response
•- Recent (within 6 weeks) acute coronary syndrome
•- Estimated glomerular filtration rate <=30 mL/min or end-stage renal disease on
•replacement therapy (dialysis)
•- 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)
•- Severe comorbid condition with life expectancy <2 years
•- Prior adverse reaction to dobutamine
•- Severe iodine contrast allergy (note: well treatable contrast allergy is
•- Pregnancy
•- Severe pulmonary hypertension with systolic pulmonary artery pressure greater
•than 50mmHg or isolated and symptomatic right ventricular failure

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