Actively Recruiting
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
Led by IRCCS Policlinico S. Donato · Updated on 2025-03-05
300
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who underwent surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) for severe aortic stenosis
- Implanted with valve models and sizes that were evaluated in vitro in this study
You will not qualify if you...
- Presence of treated or untreated aneurysm of the aortic root or ascending aorta
- Preoperative aortic valve regurgitation more than moderate
- Recent (less than 12 weeks) or concomitant coronary revascularization
- Recent (less than 12 weeks) acute coronary syndrome (ACS)
- Permanent pacemaker implantation
- Heart rhythm other than normal sinus rhythm
- Paravalvular leak greater than moderate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Policlinico di Bari
Bari, Apulia, Italy, 70100
Active, Not Recruiting
2
IRCCS Policlinico San Donato
San Donato, Lombardy, Italy, 20097
Actively Recruiting
Research Team
A
Agnese Rossi, Study Coordinator
CONTACT
G
Giacomo Bortolussi, Researcher - Cardiac Surgeon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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