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Clinical Trials/NL-OMON54218
NL-OMON54218
Completed
Not Applicable

Stress Aortic Valve Index for normal aortic valves - SAVI-NORM

Catharina-ziekenhuis0 sites8 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Catharina-ziekenhuis
Enrollment
8
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

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 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
  • \- 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

Outcomes

Primary Outcomes

Not specified

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