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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

18-75 Years
65+ Years
All
All

Not accepting

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?

Yes

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.

No

Exclusion Criteria

- aortic valve insufficiency not due to stenosis;

- refusal to participate.

Locations

Location

Status

Recruiting