OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY - Trial NCT05778773
Access comprehensive clinical trial information for NCT05778773 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS Policlinico S. Donato and is currently Recruiting. The study focuses on Aortic Valve Stenosis. Target enrollment is 1000 participants.
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Study Focus
Sponsor & Location
IRCCS Policlinico S. Donato
Timeline & Enrollment
N/A
Nov 01, 2018
Nov 01, 2029
Primary Outcome
Mortality
Summary
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05778773
Non-Device Trial