Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT04514250
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 50 years
* 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
* Ability to undergo exercise stress testing
* Ability to understand and the willingness to provide written informed consent
Exclusion Criteria:
A potential subject who meets any of the following criteria will be excluded from participation in this study
* Any hemodynamic criterion for severe AS: maximal velocity \>= 4 m/s, mean gradient \>= 40mmHg, aortic valve area =\< 1 cm2
* Percutaneous coronary intervention or coronary artery bypass grafting in the past three months, or have revascularization planned in the near future
* Known, unrevascularized, and severe coronary artery disease (for example a 90% diameter stenosis or FFR\<0.7 in the proximal left anterior descending artery)
* Impaired left ventricular function (ejection fraction \<50%)
* 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)
* 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
* Pregnancy
* Severe pulmonary hypertension with systolic pulmonary artery pressure greater than 50mmHg or isolated and symptomatic right ventricular failure
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04514250
Study Brief:
Protocol Section:
NCT04514250