Stress Aortic Valve Index for normal aortic valves

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

- 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)
- Normal LVEF (>= 50%)
- Ability to undergo (exercise) stress testing
- Ability to understand and the willingness to provide written informed consent

Exclusion Criteria

- 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
permitted)
- 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
permitted)
- Pregnancy
- Severe pulmonary hypertension with systolic pulmonary artery pressure greater
than 50mmHg or isolated and symptomatic right ventricular failure

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be purely descriptive and will include the calculation<br /><br>of mean, median, range values of the invasively measured SAVI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Correlation will be quantified by determining Peason's correlation coefficient<br /><br>between the different parameters of interest when comparing SAVI physiology and<br /><br>methodology (invasive versus non-invasive, with or without dobutamine).<br /><br>Agreement will be assessed by performing a Bland-Altman analysis. We anticipate<br /><br>that a two-dimensional scatterplot of SAVI (Ao/LV during dobutamine) versus<br /><br>Ao/LV at baseline will show a large and unpredictable heterogeneity of<br /><br>response, as we have already demonstrated for severe and low-gradient aortic<br /><br>stenosis.</p><br>