Status:
ACTIVE_NOT_RECRUITING
Stress Aortic Valve Index for Assessing Risk in Aortic Valve Stenosis Patients
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
50+ years
Brief Summary
Discrepancies exist among aortic stenosis severity classification, patient symptom burden, and - in some cases - even survival. The new Stress Aortic Valve Index (SAVI) metric correlates better with t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04514250
Start Date
April 14 2021
End Date
October 1 2028
Last Update
February 14 2024
Active Locations (5)
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1
UMass Medical Memorial Center
Worcester, Massachusetts, United States, 01655
2
UTHealth Houston, McGovern Medical School
Houston, Texas, United States, 77030
3
Aalborg University Hospital
Aalborg, Denmark
4
Catharina Hospital Eindhoven
Eindhoven, Netherlands, 5623EJ