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Clinical Trials/NL-OMON55284
NL-OMON55284
Recruiting
Not Applicable

STRESS AORTIC VALVE INDEX FOR ASSESSING RISK IN AORTIC VALVE STENOSIS PATIENTS - SAVI-AoS

Catharina-ziekenhuis0 sites30 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
narrowed heart valve
Sponsor
Catharina-ziekenhuis
Enrollment
30
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Observational invasive

Investigators

Eligibility Criteria

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

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
  • 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,

Outcomes

Primary Outcomes

Not specified

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