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

NCT05778773 | Recruiting

• 1 other identifier: OUSTANDING ITALY
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

aortic valve stenosis; aortic valve replacement; transcatheter aortic valve replacement; quality of life; patient registry

Outcome Measures

Primary Outcomes (1)

• Mortality

  Percentage of patients died

  30 days after procedure

Secondary Outcomes (1)

• Quality of life index

  Hospital discharge (average 2 to 7 days after procedure/surgery); 12-month follow-up

Study Arms (2)

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)

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)

Interventions

TAVR (Transcatheter Aortic Valve Replacement) PROCEDURE

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.

Also known as: TAVI (Transcatheter Aortic Valve Implantation)

TAVR

AVR (Aortic Valve Replacement) PROCEDURE

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.

AVR

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

RECRUITING

Related Publications (10)

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  PMID: 16980116 BACKGROUND

• Iung B, Vahanian A. Epidemiology of acquired valvular heart disease. Can J Cardiol. 2014 Sep;30(9):962-70. doi: 10.1016/j.cjca.2014.03.022. Epub 2014 Mar 21.

  PMID: 24986049 BACKGROUND

• D'Agostino RS, Jacobs JP, Badhwar V, Fernandez FG, Paone G, Wormuth DW, Shahian DM. The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2019 Update on Outcomes and Quality. Ann Thorac Surg. 2019 Jan;107(1):24-32. doi: 10.1016/j.athoracsur.2018.10.004. Epub 2018 Nov 10.

  PMID: 30423335 BACKGROUND

• Mylotte D, Osnabrugge RLJ, Windecker S, Lefevre T, de Jaegere P, Jeger R, Wenaweser P, Maisano F, Moat N, Sondergaard L, Bosmans J, Teles RC, Martucci G, Manoharan G, Garcia E, Van Mieghem NM, Kappetein AP, Serruys PW, Lange R, Piazza N. Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. J Am Coll Cardiol. 2013 Jul 16;62(3):210-219. doi: 10.1016/j.jacc.2013.03.074. Epub 2013 May 15.

  PMID: 23684674 BACKGROUND

• Cosgrove DM 3rd, Sabik JF. Minimally invasive approach for aortic valve operations. Ann Thorac Surg. 1996 Aug;62(2):596-7. No abstract available.

  PMID: 8694642 BACKGROUND

• Cribier A, Eltchaninoff H, Bash A, Borenstein N, Tron C, Bauer F, Derumeaux G, Anselme F, Laborde F, Leon MB. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation. 2002 Dec 10;106(24):3006-8. doi: 10.1161/01.cir.0000047200.36165.b8.

  PMID: 12473543 BACKGROUND

• Lababidi Z. Aortic balloon valvuloplasty. Am Heart J. 1983 Oct;106(4 Pt 1):751-2. doi: 10.1016/0002-8703(83)90097-2. No abstract available.

  PMID: 6225323 BACKGROUND

• Lababidi Z, Wu JR, Walls JT. Percutaneous balloon aortic valvuloplasty: results in 23 patients. Am J Cardiol. 1984 Jan 1;53(1):194-7. doi: 10.1016/0002-9149(84)90709-4.

  PMID: 6691261 BACKGROUND

• Bordoni B, Moretti C, Marrozzini C, Ciuca C, Dall'Ara G, Taffani L, Chiarabelli M, Taglieri N, Berardini A, Guastaroba P, Bacchi-Reggiani ML, Rapezzi C, Marzocchi A, Saia F. Repeated Aortic Balloon Valvuloplasty in Elderly Patients With Aortic Stenosis Who Are Not Candidates for Definitive Treatment. J Invasive Cardiol. 2015 Dec;27(12):E277-84. Epub 2015 Sep 15.

  PMID: 26378413 BACKGROUND

• MAGOVERN GJ, CROMIE HW. SUTURELESS PROSTHETIC HEART VALVES. J Thorac Cardiovasc Surg. 1963 Dec;46:726-36. No abstract available.

  PMID: 14099081 BACKGROUND

Related Links

• Italian Population Registry

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Central Study Contacts

Marco Ranucci, MD

CONTACT

0252774754; marco.ranucci@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cardiovascular Anesthesia and Intensive Care Department

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 21, 2023
• Study Start: November 1, 2018
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)