This study will assess the patient* health status regarding vascular symptoms after TF-AVI procedure together with stent function and the rate of stent fractures
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Vascular injuries
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Symptoms (on WIQ)
- Stent function (on echo Doppler)
- Stent fracture (on X-ray)
- Mortality and MACE
Secondary outcome
-
Background summary
In treatment with transfemoral aortic valve implantation (TF-AVI), the new
aortic valve is brought to the correct position in the hart via catheter
guiding which gets its vascular access in the groin. Vascular complications are
common (12-30%) and are caused by the large diameter opening used for the
passage of the catheter. Possible treatment for these complications is
placement of a covered stent, which is already used in treatment of peripheral
artery disease (PAD). From 2013 until today the covered stent is used in 30
patients to treat access-related vascular complications in patients who
underwent TF-AVI procedure.
Study objective
This study will assess the patient* health status regarding vascular symptoms
after TF-AVI procedure together with stent function and the rate of stent
fractures
Study design
Retrospective analyses of a (sub)cohort with repeated measurements
Study burden and risks
No serious risks are expected in this study. The radiation dose of the X-ray of
the groin is minimal (0.6 mSv), which is futile considering the age of the
patients (median age of 82 years) which already got TF-AVI treatment (with at
least ten times the radiation dose of the single X-ray we are going to make.).
The burden of this study exists of the need for an extra hospital visit to
perform the X-ray and ultrasound. Patients benefit from a closer follow-up.
This study could not be conducted in another group of patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Patient underwent TF-AVI treatment in the AMC (period 2010-2016);- Patient is treated with endovascular, covered stent in the groin area;- Patient is still alive and able to come to the AMC for a follow-up visit;- Patient gives informed consent.
Exclusion criteria
- Patient is deceased;- Patient refuses or is unable to visit the AMC for the follow-up examination
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 |
|---|---|
| CCMO | NL60455.018.17 |