The main objective of the single center, observational study is to assess the immediate and long term effects of TAVI on LVF and coronary flow by means of pressure volume loops, intracoronary flow assessment, echocardiography and cardiac MRI/CT.…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The short and long term change in left ventricular function after transcatheter
aortic valve implantation, measured invasively by means of PV-loops and
non-invasively with echocardiography and cardiac CT and MRI.
Secondary outcome
The secondary study parameters compared with baseline and, where possible,
compared between the TAVI and SAVR are: invasively measured LV systolic and
diastolic properties, coronary flow characteristics, LV ejection fraction, LV
mass, LV myocardial perfusion, flow properties across the aortic valve,
presence/amount of aortic and mitral regurgitation, right ventricular function,
cardiac conduction, mortality and morbidity, NYHA functional class and quality
of life.
Background summary
The full, precise effects of transcatheter aortic valve implantation (TAVI) on
left ventricular function (LVF) and coronary hemodynamics (CH) have not yet
been elucidated. LVF improvement after TAVI and after surgical aortic valve
replacement (SAVR) evaluated by echocardiography has been described; however,
assessment by cardiac MRI/CT scan immediately after TAVI and on long term has
not yet been described. Very limited data is available on CH after TAVI by
means of simultaneous intracoronary flow and pressure assessment.
This study is conducted as an observational study in which the effects of
transcatheter aortic valve implantation on coronary and left ventricular
hemodynamics will be assessed. Our hypothesis states that aortic pressure
gradient reduction after TAVI will improve the left ventricular dynamics
immediately after the procedure and continue to improve on the long term. With
decreased left ventricle strain and increased perfusion pressure, the coronary
hemodynamics is expected to change immediately after valve implantation. A
reduction in coronary microvascular resistance is expected on longterm, due to
a reduced ventricular hypertrophy. These changes are expected to be comparable
to those of SAVR.
Study objective
The main objective of the single center, observational study is to assess the
immediate and long term effects of TAVI on LVF and coronary flow by means of
pressure volume loops, intracoronary flow assessment, echocardiography and
cardiac MRI/CT. Where possible these effects will be compared with those of
SAVR
Study design
The study is designed as a single center observational study in which the
effects on LVF will be investigated in patients undergoing TAVI.
Study burden and risks
The extent of burden and risks is related to the assessment of PV loops and
(ideally simultaneous) coronary flow performed periprocedurally directly prior
to and after TAVI. During repeat measurements risks are related to the repeat
coronary angiography. The extra radiation exposure is minimal. Uncomplicated
assessment of PV loops has been performed in this institute during percutaneous
coronary intervention (PCI) in several studies. Also invasive coronary blood
flow measurements have been performed in many studies and as part of the
regular 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
with TAVI of high risk patients. Furthermore in case of reduced morbidity and
mortality compared to SAVR, the indications for TAVI may increase in high risk
patients. 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
transfemoral transcatheter aortic valve implantation
Exclusion criteria
coronary arteries considered unsuitable by treating interventional cardiologist.
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 | NL39660.018.12 |