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STRESS AORTIC VALVE INDEX FOR ASSESSING RISK IN AORTIC VALVE STENOSIS PATIENTS

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON55284
Enrollment
30
Registered
2020-12-04
Start date
2021-04-14
Completion date
Unknown
Last updated
2024-06-18

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

Conditions

narrowed heart valve

Interventions

None listed

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion 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 consent

Exclusion criteria

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 FFR15mm 8. Persistent atrial fibrillation with uncontrolled ventricular response 9. Recent (within 6 weeks) acute coronary syndrome 10. Estimated glomerular filtration rate =2 pulmonary inhalers (note that well-treated and stable asthma and GOLD stage 1 or 2 COPD is permitted) 12. Severe comorbid condition with life expectancy

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the evaluation of the SAVI metric as a risk predictor compared to standard echocardiographic measurements like AVA and pressure gradient at rest.

Secondary

MeasureTime frame
Secondary endpoints will include correlations between invasive and noninvasive SAVI measurements to explore if stress assessment of the aortic valve can be imaged non-invasively or if it requires invasive hemodynamic measurement. The same will be done with the cardiac CT scans that will be analyzed to see if computational fluid dynamics can simulate invasive SAVI. MRI will provide extra information for cardiac volumes, stroke volume, extracellular volume and grading of hypertrophy.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)