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RECRUITING
NCT06859255
NA

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

View on ClinicalTrials.gov

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

Interventions

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