OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY
Sponsored by IRCCS Policlinico S. Donato
About this trial
Last updated 2 years ago
Study ID
OUSTANDING ITALY
Status
Recruiting
Type
Observational [Patient Registry]
Placebo
No
Accepting
65+ Years
All
Not accepting
Healthy Volunteers
Trial Timing
Started 7 years ago
What is this trial about?
In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to
constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific
and technological research in the setting of cardiovascular diseases and related risk
factors. IRCCS (Scientific Research and Cure Institute) Policlinico San Donato is the
responsible hospital for cardiac valve pathologies and has been appointed the leader for the
present study.
The non-calcific aortic valve stenosis in the elderly is one of the most frequent
cardiovascular diseases. Different therapeutic options are available for treating this
condition: medical therapy and follow-up, conventional surgery (including sternotomy and
employment of mechanical, biological, or sutureless valves), and transcatheter valve
implantation. The uncertainty about the advantages and limitations of the different
approaches is still very high.
In this panorama, the concept of mere survival should be replaced by a broader vision of the
quality of life. The aim of the present study is to build an Italian registry of aortic valve
stenosis in the elderly (age >= 65 years) who, following the current guidelines, would
receive a biological aortic valve replacement. The following topics will be evaluated: (i)
the results of the different therapeutical options; (ii) the determination of the choice
criteria for the different therapeutical options and the verification of the appropriateness,
economic and organizational impact for each of them; (iii) the evaluation of the quality of
life modifications, periprocedural and at a long follow-up; (iv) the health technology
assessment of the applied therapies.
What are the participation requirements?
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.
Locations
Location
Status
Recruiting