Although this procedure has been performed for more than 20 years and clinical results after myectomy combined with AMVLE are satisfactory, very little is known about the effect of surgical myectomy intervention on the blood flow through the aortic…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are;
- blood flow velocity
- wall shear stress and energy loss over the aortic valve, the ascending
aorta, the aortic arch and descending aorta
Secondary outcome
Routine MRI parameters;
- enddiastolic and endsystolic volumes
- stroke volume
- ejection fraction
Background summary
Hypertrophic cardiomyopathy (HCM) is a heterogeneous disease of the myocardium
and is characterized by increased left ventricular wall thickness. Left
ventricular outflow tract (LVOT) obstruction occurs in up to 70% of patients
and is often caused by systolic anterior motion (SAM) of the mitral valve, a
paradoxical phenomenon in which the anterior mitral valve leaflet (AMVL) is
pulled towards the LVOT during systole.
The most commonly performed surgical procedure in patients with HCM is septal
myectomy, a procedure in which a part of the myocardial septum is excised,
combined with mitral valve repair which consists of anterior mitral valve
leaflet extension (AMVLE) to stiffen the midsegment of the AMVL.
Study objective
Although this procedure has been performed for more than 20 years and clinical
results after myectomy combined with AMVLE are satisfactory, very little is
known about the effect of surgical myectomy intervention on the blood flow
through the aortic valve and into the aortic root and ascending aorta.
Therefore, the aim of this study is to investigate blood flow patterns and wall
shear stress in patients after surgical septal myectomy +/- mitral valve
repair.
Study design
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 that underwent septal myectomy +/- mitral valve repair due to
hypertrophic cardiomyopathy
Exclusion criteria
- Have underwent a cardiac reoperation after the initial surgical myectomy +/-
MVR procedure
- Have major comorbidity besides HCM
- 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 | NL79654.018.21 |