In-vitro Benchmarking of Currently Available Heart Valve Prostheses for Surgical and Percutaneous Treatment of Aortic Stenosis With Small Annulus, Followed by In-vivo Validation
Recruiting
N/AInterventional Study
Severe Aortic Valve Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
200 (estimated)
Sponsor
IRCCS Policlinico S. Donato · Other
Who this trial is looking for
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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 M…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* patients who underwent SAVR or TAVI for severe aortic stenosis
* implanted with valve models and sizes among those which we evaluated in vitro
Exclusion Criteria:
* treated or untreated aortic root/ascending aorta aneurysm
* preoperative aortic regurgitation more than modera…
Inclusion Criteria:
* patients who underwent SAVR or TAVI for severe aortic stenosis
* implanted with valve models and sizes among those which we evaluated in vitro
Exclusion Criteria:
* treated or untreated aortic root/ascending aorta aneurysm
* preoperative aortic regurgitation more than moderate
* recent (\<12 weeks)/ concomitant revascularization
* recent (\<12 weeks) ACS
* PPI (permanent pacemaker implantation)
* other than sinus rythm
* Paravalvular leak (PVL) \> moderate.
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