Clinical trial Recruiting at 1 site Observational Ages 65 and up

Evaluating treatments for severe aortic valve stenosis in elderly patients in Italy

Official title: OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

Run by IRCCS Policlinico S. Donato · NCT05778773 · Data updated 2026-11-12

This study is trying to see which treatments work best for elderly patients with severe aortic valve stenosis who need valve replacement, to improve their quality of life.

More Aortic Valve Stenosis trials

Quick facts

Study typeObservational
Ages65 Years and up
SexAll
Enrollment1000 (estimated)
SponsorIRCCS Policlinico S. Donato
Academic / other
Locations1 site (San Donato Milanese, MI)
StatusRecruiting
StartedNovember 1, 2018
Main results expectedNovember 2028
Study endsNovember 2029
Registry record updatedMarch 21, 2023
Trial IDNCT05778773 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are elderly individuals aged 65 and older diagnosed with aortic valve stenosis requiring valve replacement.

Probably not a fit

Patients with aortic valve insufficiency not caused by stenosis or those who refuse to participate will not benefit from this study.

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

What this trial studies

This observational study aims to create a registry for elderly patients (aged 65 and older) with aortic valve stenosis who are eligible for valve replacement. It will assess various treatment options, including medical therapy, conventional surgery, and transcatheter aortic valve replacement (TAVR), to determine their advantages and limitations. The study is led by IRCCS Policlinico San Donato, which is responsible for cardiac valve pathologies, and seeks to enhance understanding of treatment outcomes beyond mere survival, focusing on quality of life. The registry will help inform future therapeutic strategies for this growing patient population.

Why it matters

Potential benefit: If successful, this study could improve treatment strategies and quality of life for elderly patients with aortic valve stenosis.

How similar studies have gone: Other studies have explored treatment options for aortic valve stenosis, but this registry approach focusing on quality of life in the elderly is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* age higher or equal to 65 years;
* aortic valve stenosis that, according to current guidelines, should be treated by a valve replacement;
* written consent to participate.

Exclusion Criteria:

* aortic valve insufficiency not due to stenosis;
* refusal to participate.

Where it's running

  • IRCCS Policlinico San Donato
    San Donato Milanese, Mi, Italy
    Recruiting

Study contacts

Similar studies

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

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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.