STRESS AORTIC VALVE INDEX FOR ASSESSING RISK IN AORTIC VALVE STENOSIS PATIENTS

Recruiting

• Conditions: narrowed heart valve; 10046973

• Registration Number: NL-OMON55284
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

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
consent

Exclusion Criteria

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
artery)
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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified