The main objective of the single center, observational study is to assess the immediate and long term effects of PAVI 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
(percutaneous) 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 PAVI 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, microcirculation, mortality and morbidity, NYHA functional
class and quality of life, Von Willebrand factor activity and blood levels of
NT-pro-BNP and other markers of heart failure.
Background summary
The precise effects of percutaneous aortic valve implantation (PAVI) on left
ventricular function (LVF) and coronary hemodynamics (CH) have not been
clarified yet. In the literature an observation has been described that the LVF
improves after PAVI and after surgical aortic valve replacement (SAVR). This
has been evaluated by echocardiography, but instantaneous assessment of LV
dynamic parameters by means of pressure volume loops and cardiac MRI/CT scan
immediately after PAVI and on long term has not yet been described. Also the
change in CH after PAVI by means of intracoronary flow assessment has not been
described before. This study is conducted as an observational study in which
the effects on LVF after PAVI will be compared to the effects on LVF after
SAVR. Our hypothesis is that by reducing the aortic pressure gradient after
PAVI, the left ventricular dynamics will improve immediately after the
procedure and continue to improve on the long term. These 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 PAVI 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 an observational investigation in which the effects on
LVF will be investigated in patients undergoing PAVI or SAVR.
Study burden and risks
The extent of burden and risks is related to the assessment of PV loops and
simultaneous coronary flow performed periprocedurally directly prior to and
after PAVI. 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 PAVI. The knowledge
gained by this study can be passed to other interventional cardiologists to
improve future treatment with PAVI of high risk patients. Furthermore if LV and
coronary hemodynamic effects of PAVI are shown to be non-inferior compared to
those of SAVR, the indications for PAVI could be expanded to patients with a
lower surgical risk. Lastly patients may benefit directly from this study
because of an improved follow-up.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
- Severe symptomatic native aortic valve stenosis
- Percutaneous or surgical aortic valve replacement (with biological valve prosthesis)
- Age above 75 years with one or more surgical risk factors
Exclusion criteria
- Previous aortic valve replacement
- Surgical aortic valve replacement combined with CABG or other valve surgery
- Severe left ventricular dysfunction
- Severe infection
- Recent myocardial infarction or stroke
- Enrolled in another investigational study
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 | NL27918.018.09 |