Clinical Trial

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

Study acronym: SurPASS
Recruiting
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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.
Trial Details
NCT Number NCT06859255
Lead Sponsor IRCCS Policlinico S. Donato
Conditions Severe Aortic Valve Stenosis
Enrollment 200 participants
Start Date 2025-02-07
Primary Completion 2027-02-07 (estimated)
Study Completion 2027-02-07 (estimated)
Updated on ClinicalTrials.gov 2026-07-02