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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Contact Information
Primary
Marco Ranucci, MD
marco.ranucci@grupposandonato.it
0252774754
Time Frame
Start Date: 2018-11-01
Estimated Completion Date: 2029-11
Participants
Target number of participants: 1000
Treatments
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).
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).
Sponsors
Leads: IRCCS Policlinico S. Donato

This content was sourced from clinicaltrials.gov