Comparing heart valve prostheses for treating aortic stenosis
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
This study is testing how well different types of heart valve replacements work for people with severe aortic stenosis, especially those with smaller heart openings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 2 sites (Bari, Apulia and 1 other locations) |
| Trial ID | NCT06859255 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the hemodynamic performance of various aortic valve prostheses through both in vitro and in vivo methods. It involves collecting data from standard clinical procedures, including echocardiograms and 4D Flow cardiac MRI, to assess the performance of these valves after surgical implantation. The study will last for 24 months, with patient involvement concluding 1-3 months post-intervention. The focus is on patients with severe aortic valve stenosis, particularly those with small aortic annuli, to understand how different prostheses perform under simulated and real conditions.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) for severe aortic stenosis.
Not a fit: Patients with significant aortic regurgitation, recent revascularization, or other specific cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes for patients undergoing valve replacement for aortic stenosis.
How similar studies have performed: Other studies have explored similar methodologies in valve performance assessment, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bari, Apulia and 1 other locations
- Policlinico di Bari — Bari, Apulia, Italy (Active_not_recruiting)
- IRCCS Policlinico San Donato — San Donato, Lombardy, Italy (Recruiting)
Study contacts
- Study coordinator: Agnese Rossi, Study Coordinator
- Email: agnese.rossi@grupposandonato.it
- Phone: 00393409009040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.