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

March 10, 2023 updated by: Marco Ranucci, IRCCS Policlinico S. Donato

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 proportion of the elderly in the general population is constantly increasing over the last few years and is destined to grow further in industrialized countries, representing a challenge for the sanitary authorities for a number of reasons.

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 (TAVI). The uncertainty about the advantages and limitations of the different approaches is still very high.

In this panorama, 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 an extended follow-up; (iv) the health technology assessment of the applied therapies.

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized due to aortic valve stenosis that is to be treated, according to the current guidelines, through a replacement, be it a percutaneous procedure (transcatheter aortic valve replacement) or an open-heart surgery (sternotomy, cardiopulmonary bypass, and biological aortic valve implantation), as agreed between the cardiologist, the surgeon, the anesthesiologist, and the patient.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
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.
Other Names:
  • TAVI (Transcatheter Aortic Valve Implantation)
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 30 days after procedure
Percentage of patients died
30 days after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life index
Time Frame: Hospital discharge (average 2 to 7 days after procedure/surgery); 12-month follow-up
Index of well-being assessed through a questionnaire
Hospital discharge (average 2 to 7 days after procedure/surgery); 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2018

Primary Completion (Anticipated)

November 1, 2028

Study Completion (Anticipated)

November 1, 2029

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 10, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OUSTANDING ITALY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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