Skip to content

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

Early vs. late mobilisation after Transcatheter Femoral Aortic Valve Implantation (TF-AVI)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21755
Enrollment
Unknown
Registered
2016-09-13
Start date
2016-10-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

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. )

Interventions

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 durin

Sponsors

Academical medical centre of Amsterdam
Lead Sponsor

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

MeasureTime frame
-Vascular and bleedingcomplications -Pain and patient comfort

Secondary

MeasureTime 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

Public ContactJeroen Vendrik

Meibergdreef 9 (Academical Medical Centre Amsterdam)

j.vendrik@amc.uva.nl+31 (0)20 566 5204 / +316 46032024

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)