Evaluating treatments for severe aortic valve stenosis in elderly patients in Italy
OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY
IRCCS Policlinico S. Donato · NCT05778773
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 |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | IRCCS Policlinico S. Donato (other) |
| Locations | 1 site (San Donato Milanese, MI) |
| Trial ID | NCT05778773 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are elderly individuals aged 65 and older diagnosed with aortic valve stenosis requiring valve replacement.
Not a fit: Patients with aortic valve insufficiency not caused by stenosis or those who refuse to participate will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Donato Milanese, MI
- IRCCS Policlinico San Donato — San Donato Milanese, MI, Italy (RECRUITING)
Study contacts
- Study coordinator: Marco Ranucci, MD
- Email: marco.ranucci@grupposandonato.it
- Phone: 0252774754
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.
Conditions: Aortic Valve Stenosis, aortic valve stenosis, aortic valve replacement, transcatheter aortic valve replacement, quality of life, patient registry