About this trial
The general objective of this study is to compare in vitro and in vivo the hemodynamic performance of different types of aortic valve prostheses and possible surgical implantation techniques.
The study involves the collection of data deriving from tests and procedures foreseen by normal clinical practice, including a transthoracic color Doppler echocardiogram, to which is added a 4DFlow cardiac MRI (magnetic resonance imaging) without contrast medium, to be performed between 1 and 3 months after the operation.
The study will last 24 months and the patients involvement will end approximately 1-3 months after the intervention.
There are no direct benefits expected from participation in the study. However, the instrumental data obtained by echocardiogram and Magnetic Resonance Imaging will be useful for monitoring the medium-term surgical outcome of patients after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients who underwent SAVR or TAVI for severe aortic stenosis
implanted with valve models and sizes among those which we evaluated in vitro
Disqualifiers
treated or untreated aortic root/ascending aorta aneurysm
preoperative aortic regurgitation more than moderate
recent (<12 weeks)/ concomitant revascularization
recent (<12 weeks) ACS
Trial design
Single group
Treatments tested in this trial
MRI
Diagnostic testThe patients will be undergo to a MRI without contrast after 1 month from the procedure/surgery to test the hwmodynamic performance 4d flow in the implanted valve
Treatment groups
Trial outcomes
Primary outcomes
Bench tests performance
Pressure gradient after valve implantation in vitro
MRI in vitro
Blood flow pattern of aortic in vitro models under 4D flow MRI
Echo in vivo
Morphology of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo
Echo in vivo
Motiliy of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo
Sponsors and contacts
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