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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Primary outcome measure(s)

• Bench tests performance — 24 months
  Pressure gradient after valve implantation in vitro
• MRI in vitro — 24 months
  Blood flow pattern of aortic in vitro models under 4D flow MRI
• Echo in vivo — 24 months
  Morphology of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo
• Echo in vivo — 24 months
  Motiliy of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo
• RMN in vivo — 24 months
  Blood flow pattern of implanted valves will be evaluated in vivo through a MRI 4 flow

Trial sites (2)

More IRCCS Policlinico S. Donato trials in Italy