Comparing heart valve prostheses for treating aortic stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Policlinico di Bari
  Bari, Apulia, Italy 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry for patients with severe aortic valve stenosis undergoing TAVR with Myval valve

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• Personalized antithrombotic therapy for patients after aortic valve replacement

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• Evaluating treatment options for aortic valve stenosis

  This study is testing how different treatments for aortic valve stenosis, like surgery and other options, affect patients' quality of life and survival.

  Recruiting St. Antonius Hospital · Nieuwegein · NCT06168123

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.