The objective is to assess the degree of under- and overexpansion and malapposition of the CRS after implantation, and to come with a proposal of sizing based upon observations made in a (large) prospective clinical data set-experience. For this…
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine which dimensions of the aortic root are optimal to guide
prosthesis size selection
Secondary outcome
- The quantitative and qualitative assessment of the geometry and degree of
deformation of the PAVR prostheses with MSCT
- To investigate the association between aortic regurgitation (valvular and
para-valvular) post PAVR and 1) prosthesis sizing (degree of expansion,
asymmetry and apposition) and 2) position (depth of implantation)
Background summary
Up to 30 to 60% of patients with severe aortic stenosis do not receive surgical
valve replacement because of perceived prohibitive risk. In these high risk
patients, who are not treated surgically, medical therapy is associated with
considerable morbidity and high mortality. Percutaneous aortic valve
replacement (PAVR) is an increasingly important treatment alternative this
patient group. However, much still needs to be learned about the percutaneous
approach as reflected by the high complication rates so far reported albeit in
high risk patients.
Study objective
The objective is to assess the degree of under- and overexpansion and
malapposition of the CRS after implantation, and to come with a proposal of
sizing based upon observations made in a (large) prospective clinical data
set-experience. For this purpose, MSCT will be performed before and after
implantation in patients with aortic stenosis who are scheduled for PAVR.
Study design
Prospective observational cohort study.
Study burden and risks
A MSCT is hardly seen as an invasive procedure
's-Gravendijkwal 230
3065 CE Rotterdam
NL
's-Gravendijkwal 230
3065 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patient scheduled for percutaneous Aortic valve replacement
Exclusion criteria
- Severe allergy to radiocontrast (previous anaphylaxis/angio-oedema)
- Severely irregular heart rhythm precluding diagnostic MSCT images
- Inability to breath hold for the duration of an MSCT scan
- Patients with severe renal impairment (estimated GFR below 20ml/min) will not be eligible for MSCT with contrast
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 | NL26342.078.09 |