Patients with severe aortic stenosis (eligible for invasive treatment which are not suitable for conventional surgical aortic valve replacement and thus eligible for T(F)AVI. )
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - All TF-AVI patients at the AMC
Exclusion criteria
Exclusion criteria: - Pre-existent problems with mobility (i.e. wheelchair indepency, inability to transfer) - Pre-TAVI INR>2,0 - Heparine-infusor after TAVI-procedure - Need for vascular closure by (vascular) surgeon at catheterisation room - Operator’s opinion (difficult access site closure; >20 minutes manual pressure needed before hemostasis is reached) - Temporary pacemaker placement - Contra-indications at secondary assessment (+4 hrs after procedure) o Symptomatic hypotension o Active bleeding o Hematoma (> 5cm diameter) o Rhythm or conduction disorders on ECG o Extreme pain at access site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Vascular and bleedingcomplications -Pain and patient comfort | — |
Secondary
| Measure | Time frame |
|---|---|
| - Infection rate - Need for, and time of, CAD in situ - Quality of life (SF-36 and EQ-5D questionnaire) - Hospitalisation stay duration - Delirium | — |
Contacts
Meibergdreef 9 (Academical Medical Centre Amsterdam)