NCT06859255 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
| NCT ID | NCT06859255 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Policlinico S. Donato |
| Condition | Severe Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-02-07 |
| Primary Completion | 2027-02-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-02-07 with a primary completion date of 2027-02-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06859255 clinical trial?
This trial is open to participants of all sexes, studying Severe Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06859255 currently recruiting?
Yes, NCT06859255 is actively recruiting participants. Contact the research team at agnese.rossi@grupposandonato.it for enrollment information.
Where is the NCT06859255 trial being conducted?
This trial is being conducted at Bari, Italy, San Donato, Italy.
Who is sponsoring the NCT06859255 clinical trial?
NCT06859255 is sponsored by IRCCS Policlinico S. Donato. The trial plans to enroll 200 participants.