RecruitingNot ApplicableNCT06859255

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

Enrollment

300 participants

Start Date

Feb 7, 2025

Study Type

INTERVENTIONAL

Conditions

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

Inclusion Criteria2

  • patients who underwent SAVR or TAVI for severe aortic stenosis
  • implanted with valve models and sizes among those which we evaluated in vitro

Exclusion Criteria7

  • 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.

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Interventions

DIAGNOSTIC_TESTMRI

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

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NCT06859255


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