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Taking people in ItalyNo phase

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

Key facts

Who runs it
IRCCS Policlinico S. Donato
Where
Bari and San Donato, ItalySee the 2 sites
Trial code
Status
Recruiting
People taking part
200 people, planned
Started
7 Feb 2025
Expected to end
7 Feb 2027
Type of study
Interventional
Treatments tested
  • MRI
Record updated
2 July 2026

Who can take part

Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • patients who underwent SAVR or TAVI for severe aortic stenosis
  • implanted with valve models and sizes among those which we evaluated in vitro

Who cannot take part

  • recent (<12 weeks)/ concomitant revascularization
  • treated or untreated aortic root/ascending aorta aneurysm
  • preoperative aortic regurgitation more than moderate
  • recent (<12 weeks) ACS
  • PPI (permanent pacemaker implantation)
  • other than sinus rythm
  • Paravalvular leak (PVL) > moderate

Where in Italy

  • Policlinico di BariBari, ItalyContact: Nicola Vitale, Researcher - Cardiac SurgeonTaking people
  • IRCCS Policlinico San DonatoSan Donato, ItalyContact: Agnese Rossi, Study coordinatorTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Aortic Valve Replacement PatientTreatment being tested

    Inclusion criteria: * evaluation of 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 or recent (\<12 weeks) ACS Timing of trans-thoracic echocardiography (TTE) and MRI: 1 to 3 months after SAVR/TAVR. Intervention: MRI, it is not clinical practice during 1 month follow-up. Clinical Variables: in order to reduce clinical bias in the comparison of the two populations, at the moment of TTE exam, blood pressure, heart rate and haemoglobin values will be recorded.

    Treatment: MRI

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
2 July 2026