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

NCT05778773 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-03-21

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

Interventions

PROCEDURE

TAVR (Transcatheter Aortic Valve Replacement)

Percutaneous aortic valve replacement, also known as percutaneous aortic valve implantation, transcatheter aortic valve implantation or transcatheter aortic valve replacement, is the replacement of the aortic valve of the heart through the blood vessels.

PROCEDURE

AVR (Aortic Valve Replacement)

Aortic valve replacement is a procedure whereby the failing aortic valve of a patient's heart is replaced with an artificial heart valve through an open-heart surgery.

Sponsors & Collaborators

  • IRCCS Policlinico S. Donato

    lead OTHER

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2028-11-30
Completion
2029-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05778773 on ClinicalTrials.gov