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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

RecruitingNAAges any - anyAllIRCCS Policlinico S. Donato
NCT06859255 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * patients who underwent SAVR or TAVI for severe aortic stenosis * implanted with valve models and sizes among those which we evaluated in vitro Exclusion Criteria: * 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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What it tests

  • MRI
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Where

2 sites
Policlinico di Bari
Bari, Italy
IRCCS Policlinico San Donato
San Donato, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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