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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
Sponsor: IRCCS Policlinico S. Donato
Summary
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.
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-02-07
Completion Date
2027-02-07
Last Updated
2025-03-05
Healthy Volunteers
No
Conditions
Interventions
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