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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorIRCCS Policlinico S. Donato

About this trial

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 criteria

Qualifiers

patients who underwent SAVR or TAVI for severe aortic stenosis

implanted with valve models and sizes among those which we evaluated in vitro

Disqualifiers

treated or untreated aortic root/ascending aorta aneurysm

preoperative aortic regurgitation more than moderate

recent (<12 weeks)/ concomitant revascularization

recent (<12 weeks) ACS

Trial design

Treatments tested in this trial

  • MRI

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators