To determine the effects of surgical and transcatheter (transapical, transfemoral or transaortal) aortic valve replacement on patient neuropsychological functioning which provides the opportunity to prematurely establish subclinical effects that may…
ID
Source
Brief title
Condition
- Cardiac valve disorders
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neuropsychological functioning, specifically the following domains:
- executive functioning and attention
- memory
- language
- visual spatial functioning
- psychomotor speed
Secondary outcome
Degree of anxiety and depression before and after surgical/transcatheter aortic
valve replacement
Quality of life before and after surgical/transcatheter aortic valve
replacement
Background summary
Not all patients with severe aortic valve stenosis are suitable for surgical
aortic valve replacement. Transcatheter aortic valve replacement, a relatively
novel procedure, was developed as a suitable alternative to treat this high
risk patient population with different comorbidities. A bioprosthetic valve is
inserted either via the transfemoral, transapical or transaortic route using a
catheter. During deployment of the bioprosthetic valve the old valve is crushed
against the aortic wall. MRI studies show that in a majority of patients this
causes microdebris that reaches the brain via the carotid arteries. A recent
randomized controlled trial shows that compared to surgical aortic valve
replacement, the percuteous procedure is associated with significantly more
cerebrovascular events. However, it is unclear what the effects are of
percuteous aortic valve replacement on neuropsychological functioning and the
quality of life of the patient.
Study objective
To determine the effects of surgical and transcatheter (transapical,
transfemoral or transaortal) aortic valve replacement on patient
neuropsychological functioning which provides the opportunity to prematurely
establish subclinical effects that may positively influence quality of life.
Study design
120 consecutive patients above the age of 18 years of age with an indication
and accepted for:
- transcatheter aortic valve replacement
- surgical aortic valve replacement
will be asked for participation in this single center prospective observational
study shortly after acceptance for treatment.
Study burden and risks
not applicable
Meibergdreef 9 (B2-137)
1105AZ Amsterdam
NL
Meibergdreef 9 (B2-137)
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Patients above 18 years of age requiring and accepted for surgical aortic valve replacement
Patients aboven 18 years of age requiring and accepted for transcatheter aortic valve replacement
Exclusion criteria
Psychiatric comorbidity that might influence neuropsychological functioning
Physical dysfunction that might influence neuropsychological functioning
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 | NL37486.018.12 |