The aim of this study is to investigate potential differences in blood flow patterns, wall shear stress and energy loss in patients after mitral valve repair with the resect and respect approach.
ID
Source
Brief title
Condition
- Cardiac valve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are;
- blood flow velocity (kinetic energy and turbulent kinetic energy) in the left
atrium, left ventricle, over the aortic valve, in the ascending aorta, the
aortic arch and the descending aorta
- energy loss in the left atrium, left ventricle, over the aortic valve, in the
ascending aorta, the aortic arch and the descending aorta
- trans-valvular flow quantification of the mitral valve
All outcomes will be compared to available reference values in healthy
subjects.
Secondary outcome
Routine MRI parameters;
- enddiastolic and endsystolic volumes
- stroke volume
- ejection fraction
Background summary
Primary mitral regurgitation due to degenerative valve disease is a common
cardiac disease. Mostly, the mechanism behind this disease is a prolapse of the
posterior 2 leaflet segment of the mitral valve. Ultimate treatment for
patients suffering from this disease is mitral valve repair surgery. For this
procedure there are two main techniques which are considered equal. These are
the 1) resect approach in which the diseased leaflet segment is resected and
the remaining segments are sutured together and the 2) respect approach in
which the prolapsed leaflet segment is resuspended by implantation of artifical
chordae.
Earlier studies have investigated whether there are differences between these
two approaches regarding clinical outcome. However, results show outcomes in
favor of both strategies. This indicates the need for a more precise approach
of investigation.
Hemodynamic changes after surgery play an important role in the clinical
outcome of these patients. Yet, despite the fact that these surgical approaches
are performed for more than 30 years and results for both techniques are
satisfactory, knowledge about the effect on post-operative blood flow patterns
in these patients remains limited.
Study objective
The aim of this study is to investigate potential differences in blood flow
patterns, wall shear stress and energy loss in patients after mitral valve
repair with the resect and respect approach.
Study design
Prospective single center pilot study
Study burden and risks
Since all the elements of this study are harmless and carry no risk, the
overall risk is considered minimal.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients who have undergone surgical mitral valve repair - more than 1 year ago
- for mitral regurgitation due to a prolapse of the P2 leaflet segment of the
mitral valve.
Exclusion criteria
- Have underwent a cardiac reoperation after the initial mitral valve repair
procedure
- Have major comorbidity besides mitral regurgitation
- Are under the age of 18.
- Have claustrophobia or another contra-indication for MRI.
- Are not able to provide written informed consent.
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 | NL83026.018.22 |