NCT05778773

OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

IRCCS Policlinico S. Donato·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Aortic Valve Stenosis
Drug/Device/Intervention
TAVR (Transcatheter Aortic Valve Replacement)
Study type
Observational
Intervention type
procedure
Sponsor & location
Primary sponsor
IRCCS Policlinico S. Donato
Location
San Donato Milanese, Italy
Timeline & enrollment
Phase
N/A
Start date
Nov 01, 2018
End date
Nov 01, 2029
Enrollment
1000 participants
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
Aortic (valve) stenosisAortic (valve) stenosis with insufficiencyCongenital stenosis of aortic valveStenosis of aortaRheumatic aortic stenosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05778773
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.