Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
NCT ID: NCT01852552
Last Updated: 2016-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
518 participants
OBSERVATIONAL
2011-12-31
2016-01-31
Brief Summary
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The objectives of the study are:
1. Description of neurocognitive status before and after transcatheter aortic valve implantation and aortic valve replacement procedures
2. Description of Quality of Life (QoL) after these procedures
3. Defining the relevance of baseline psychological, emotional and cognitive factors on the outcomes associated to the different treatment modalities
4. Assessment of costs associated to each of the above mentioned strategies of treatment, including costs of the index hospitalization and costs of follow-up.
Detailed Description
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All consecutive patients undergoing transcatheter aortic valve implantation or aortic valve replacement (if age ≥ 80 years or Logistic Euroscore ≥ 15%) for aortic stenosis at participating centers during the period of enrollment will be included in the registry, after release of written informed consent. Allocation of patients to different treatment groups will be performed jointly by a cardiologist and a cardiac surgeon on the basis of a complete clinical framework, independently from the present study and in accordance with available guidelines. Type of treatment (for example, access site for TAVI, type of prosthesis…) will be decided by the physicians based on local clinical practice and general principles of good clinical practice.
The administration of neurocognitive and quality of life questionnaires will be performed before the procedure and after 3 months and 1 year by trained personnel following standard operation procedures defined by a coordinating unit. A telephone and web-based support for operators will be available throughout the entire duration of the study. A common methodology for data collection and analysis is defined to guarantee data reliability and homogeneity of assessments among the participating units. The cost analysis will be coordinated by the Regional Healthcare and Social Agency of the Emilia Romagna Region.
Data will be collected in a web-based database (OBSERVANT) through dedicated Case Records Forms and a final database will be built by merging this database with a separate database for costs and Hospital Discharge Records and Mortality Registry databases.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Transcatheter aortic valve implantation
All consecutive patients undergoing TAVI at participating centres during study period
transcatheter aortic valve implantation
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Aortic Valve Replacement
All consecutive patients aged ≥ 80 years or with Logistic Euroscore≥ 15% undergoing AVR for AS at participating centers during the period of enrollment
Aortic Valve Replacement
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
Interventions
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transcatheter aortic valve implantation
Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
Aortic Valve Replacement
Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All consecutive patients aged ≥80 years or with Logistic Euroscore ≥15% undergoing AVR at participating centers during the period of enrollment
Exclusion Criteria
ALL
No
Sponsors
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Ministry of Health, Italy
OTHER_GOV
Region Emilia-Romagna, Italy
UNKNOWN
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Responsible Party
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Francesco Saia, MD, PhD
Dr.
Locations
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Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, , Italy
Countries
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Other Identifiers
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GR-2009-1578270
Identifier Type: -
Identifier Source: org_study_id