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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - patients who underwent SAVR or TAVI for severe aortic stenosis - implanted with valve models and sizes among those which we evaluated in vitro Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

MRI

The 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

Locations (2)

Policlinico di Bari
Bari, Apulia, Italy
IRCCS Policlinico San Donato
San Donato, Lombardy, Italy