The main objective of the single center, observational study is to assess the immediate and long term effects of TAVI on biomarkers, correlated to clinical outcomes.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is to document the course of biomarkers around
transcatheter aortic valve implantation.
Secondary outcome
The course of biomarkers will be correlated to short and long term clinical
outcomes and change in left ventricular function after transcatheter aortic
valve implantation, measured non-invasively with echocardiography and cardiac
CT and MRI,
Background summary
The precise effects of transcatheter aortic valve implantation (TAVI)
correlated to biomarkers have not been clarified yet. This study is conducted
as an observational study in which the time course of biomarkers will be
documented and will be correlated to the clinical outcomes and the effects on
LVF after TAVI. Our hypothesis is that TAVI will improve the left ventricular
dynamics immediately after the procedure and continue to improve on the long
term.
Study objective
The main objective of the single center, observational study is to assess the
immediate and long term effects of TAVI on biomarkers, correlated to clinical
outcomes.
Study design
The study is designed as an observational investigation in which the course of
biomarkers after TAVI will be correlated to clinical outcomes.
Study burden and risks
The extent of burden and risks is related to the extra blood samples obtained
during routing blood drawings for standard patient care. The benefit of this
study is a better understanding of mechanisms of LVF improvement after TAVI.
The knowledge gained by this study can be passed to other interventional
cardiologists to improve future treatment of high risk patients with TAVI.
Lastly patients may benefit directly from this study because of an improved
follow-up.
meibergdreef 9
Amsterdam 1105AZ
NL
meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
transcatheter aortic valve implantation
Exclusion criteria
No additional exclusion criteria besides exclusion criteria for transcatheter aortic valve implantation are applicable for extra blood samples
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 | NL39326.018.12 |