No registrations found.
ID
Source
Brief title
Health condition
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. )
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Vascular and bleedingcomplications
- Pain and patient comfort
Secondary outcome
- Infection rate
- Need for, and time of, CAD in situ
- Quality of life (SF-36 and EQ-5D questionnaire)
- Hospitalisation stay duration
- Delirium
Background summary
In this study we assess if it is save and better to mobilize TF-AVI patients early (4-6 hours) after the procedure. Our hypotheses is that this can be done safely and with better patient comfort, less pain complaints and lower complication rates associated with the elderly patient during hospital stay (infections, deliria).
Study objective
Early mobilisation, i.e. 6 hours after vascular closure after TF-AVI procedure, will maximize comfort, lower pain complaints, lower infection rate and raise overall patient wellbeing after TAVI-procedure without extreme increase in vascular complications (i.e. access site bleedings/hematomas)
Intervention
Either, after primary and secondary survey, early mobilisation (4-6 hours after procedure) either immobilisation according to protocol until the next morning, depending on planning of procedures during the day.
Jeroen Vendrik
Room TKs0-248
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 566 5204 / +316 46032024
j.vendrik@amc.uva.nl
Jeroen Vendrik
Room TKs0-248
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 566 5204 / +316 46032024
j.vendrik@amc.uva.nl
Inclusion criteria
- All TF-AVI patients at the AMC
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5910 |
| NTR-old | NTR6098 |
| Other | : AMCW16_289 |