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Same day mobilisation after TF-AVI procedure (MobiTAVI)?


- candidate number25285
- NTR NumberNTR6098
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2016
- Secondary IDsAMCW16_289 
- Public TitleSame day mobilisation after TF-AVI procedure (MobiTAVI)?
- Scientific TitleEarly vs. late mobilisation after Transcatheter Femoral Aortic Valve Implantation (TF-AVI)
- ACRONYMMobiTAVI
- hypothesisEarly 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)
- Healt Condition(s) or Problem(s) studiedAortic valve stenosis
- 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
- Operatorís 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
- mec approval receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2016
- planned closingdate1-okt-2017
- Target number of participants0
- InterventionsEither, 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.
- 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
- Timepoints
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Jeroen Vendrik
- CONTACT for SCIENTIFIC QUERIESDr. K.T. Koch
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
None
- Publications
- Brief summaryIn 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).
- Main changes (audit trail)
- RECORD13-sep-2016 - 25-nov-2016


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