I35.0
Conditions
Interventions
Group 1: The aim of this study is to investigate the clinical impact of routine TEE in addition to TTE for the management of patients with suspected severe aortic stenosis.
Routine TEE does not impact
Sponsors
Uniklinik Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with suspected or confirmed severe aortic valve stenosis, i.e. patients with severe or moderate-to-severe aortic stenosis on TTE.
Exclusion criteria
Exclusion criteria: • Absence of either TEE or TTE • Insufficient image quality to obtain AVA (aortic valve area) or mean gradient (dP mean) • Patients with suspected severe but confirmed moderate aortic stenosis by in-hospital TTE (without TEE) • Persons <18 years old (aortic stenosis is a disease of elderly patients. Atherosclerotic aortic stenosis does not occur in adolescents)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in severity of aortic valve stenosis on TEE (compared to the reference method), i.e. from severe to non-severe aortic stenosis or conversely. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any findings in TEE that impact the management of severe aortic stenosis, for instance thrombus, vegetations, annulus dimension, bicuspid aortic morphology etc. 2. Any findings in TEE with therapeutic implications, for instance incident left atrial thrombus. 3. Clinical outcome: time-to-aortic valve implantation/replacement, hospitalisations for cardiovascular causes, hospitalisation for heart failure, cardiovascular death, and all-cause death in patients with change in AS severity after TEE compared to patients with consistent results between TEE and TTE, i.e. unchanged severity of AS after TEE. 4. Safety of TEE: any (including suspected) complications that require medical intervention, monitoring, active follow-up or prolongation of hospital stay. | — |
Countries
Germany
Contacts
Public ContactDaniel Lavall
Uniklinik Leipzig
Outcome results
None listed