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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • MRI

    Diagnostic test

    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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Aortic Valve Replacement PatientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Bench tests performance

Pressure gradient after valve implantation in vitro

Time frame
24 months
2

MRI in vitro

Blood flow pattern of aortic in vitro models under 4D flow MRI

Time frame
24 months
3

Echo in vivo

Morphology of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo

Time frame
24 months
4

Echo in vivo

Motiliy of the bioprosthetic valve leaflets will be evaluated in vivo through an Echo

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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