Status:
COMPLETED
Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement
Lead Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborating Sponsors:
Ministry of Health, Italy
Region Emilia-Romagna, Italy
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
Brief Summary
Multicenter, prospective, observational study in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVI) or high-risk patients undergoing aortic valve replacement (AVR)...
Detailed Description
In Italy, a nation-wide observational study endorsed by the Superior Institute of Health has been previously launched in order to evaluate appropriateness and effectiveness of aortic valve replacement...
Eligibility Criteria
Inclusion
- All consecutive patients undergoing TAVI at participating centers during the period of enrollment
- All consecutive patients aged ≥80 years or with Logistic Euroscore ≥15% undergoing AVR at participating centers during the period of enrollment
Exclusion
- Absence of informed consent
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT01852552
Start Date
December 1 2011
End Date
January 1 2016
Last Update
November 15 2016
Active Locations (1)
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1
Institute of Cardiology, Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138