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

Key facts

Who runs it
IRCCS Policlinico S. Donato
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
1,000 people, planned
Started
1 Nov 2018
Expected to end
Nov 2029
Type of study
Observational, 2 groups
Treatments tested
  • TAVR (Transcatheter Aortic Valve Replacement)
  • AVR (Aortic Valve Replacement)
Record updated
21 March 2023

Who can take part

Age
65 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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

Who cannot take part

  • aortic valve insufficiency not due to stenosis
  • refusal to participate

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • TAVR

    Patients undergoing aortic valve replacement through the Transcatheter Aortic Valve Replacement procedure. For all the patients a set of clinical, anatomical, and procedural details will be obtained and registered. The outcome at the hospital discharge and at the 12-month follow-up will be collected, as well. The quality of life questionnaire will be administered to all the patients at the hospital discharge, at the 12-month follow-up (mandatory), and then at annual base (facultative).

    Treatment: TAVR (Transcatheter Aortic Valve Replacement)

  • AVR

    Patients undergoing aortic valve replacement through conventional open-heart surgery (sternotomy and biological valve implantation). For all the patients a set of clinical, anatomical, and procedural details will be obtained and registered. The outcome at the hospital discharge and at the 12-month follow-up will be collected, as well. The quality of life questionnaire will be administered to all the patients at the hospital discharge, at the 12-month follow-up (mandatory), and then at annual base (facultative).

    Treatment: AVR (Aortic Valve Replacement)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
21 March 2023