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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | IRCCS Policlinico S. Donato Academic / other |
| Locations | 1 site (San Donato Milanese, MI) |
| Status | Recruiting |
| Started | November 1, 2018 |
| Main results expected | November 2028 |
| Study ends | November 2029 |
| Registry record updated | March 21, 2023 |
| Trial ID | NCT05778773 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
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IRCCS Policlinico San Donato
San Donato Milanese, Mi, Italy Recruiting
Study contacts
- Study coordinator: Marco Ranucci, MD
- Email: marco.ranucci@grupposandonato.it
- Phone: 0252774754
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Transcatheter Aortic Valve Replacement Registry for Outcomes and Quality Monitoring
This registry collects information from hospitals about patients undergoing TAVR to see how care and outcomes compare to guidelines and nationwide data.
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Vericiguat to slow calcific aortic valve narrowing
This trial tests whether vericiguat can slow the progression of mild-to-moderate calcific aortic valve stenosis compared with placebo.
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CHATEAU Registry: Real-world outcomes after TAVR
This registry collects real-world data from adults who had TAVR between 2021 and 2025 to see how they do over time and how valve performance holds up.
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Impact of TAVR on kidney function in people with aortic valve disease
This registry tests how trans-catheter aortic valve implantation affects kidney function and the risk of kidney injury in adults with aortic stenosis.
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Hydra THV Transfemoral Valve Implantation in Severe Aortic Stenosis
This registry tests how safely and effectively the Hydra THV works when implanted through the femoral artery in adults with severe symptomatic aortic stenosis.
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How the type of sedation affects recovery after TAVR
This study will test whether three common sedation approaches (propofol, dexmedetomidine, or midazolam with fentanyl) change how people recover on the first day after transfemoral TAVR.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.