Stress Aortic Valve Index for normal aortic valves

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54218

Enrollment

Registered

2021-10-20

Start date

2022-01-11

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

narrowed aortic valves

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - No important aortic stenosis (AVA > 1.5 cm2, MAG = 50%) - Ability to undergo (exercise) stress testing - Ability to understand and the willingness to provide written informed consent

Exclusion criteria

Exclusion criteria: - Any hemodynamic criterion for moderate or greater AS - Known, unrevascularized, and severe coronary artery disease (for example a 90% diameter stenosis or FFR15mm - Persistent atrial fibrillation with uncontrolled ventricular response - Recent (within 6 weeks) acute coronary syndrome - Estimated glomerular filtration rate =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

Design outcomes

Primary

Measure	Time frame
The primary outcome will be purely descriptive and will include the calculation of mean, median, range values of the invasively measured SAVI.	—

Secondary

Measure	Time frame
Correlation will be quantified by determining Peason's correlation coefficient between the different parameters of interest when comparing SAVI physiology and methodology (invasive versus non-invasive, with or without dobutamine). Agreement will be assessed by performing a Bland-Altman analysis. We anticipate that a two-dimensional scatterplot of SAVI (Ao/LV during dobutamine) versus Ao/LV at baseline will show a large and unpredictable heterogeneity of response, as we have already demonstrated for severe and low-gradient aortic stenosis.	—

Measure

Time frame

Correlation will be quantified by determining Peason's correlation coefficient between the different parameters of interest when comparing SAVI physiology and methodology (invasive versus non-invasive, with or without dobutamine). Agreement will be assessed by performing a Bland-Altman analysis. We anticipate that a two-dimensional scatterplot of SAVI (Ao/LV during dobutamine) versus Ao/LV at baseline will show a large and unpredictable heterogeneity of response, as we have already demonstrated for severe and low-gradient aortic stenosis.

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Countries

Netherlands

Outcome results