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

Recruiting now · Not applicable

Conditions studied: Severe Aortic Valve Stenosis

In brief

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.

Key facts

Study ID

NCT06859255

Run by

IRCCS Policlinico S. Donato

People needed

200

Starts

2025-02-07

Expected to finish

2027-02-07

Last updated by the study team

2026-07-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Policlinico di Bari — Bari, Apulia, Italy (enrolling)
• IRCCS Policlinico San Donato — San Donato, Lombardy, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.