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NCT05912660 Clinical Trial

Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis

Aortic Valve Disease Clinical Trial

Official title:
Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05912660
Other study ID # AUTHEARTVISIT - TAVI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2020

Study information
Verified date June 2023
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall project aim is to study outcomes following aortic valve replacement with surgically implanted bioprostheses or TAVI by retrieving data from the main social security carriers in Austria for the years 2010-2020.

Recruitment information / eligibility
Status Completed
Enrollment 18882
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years to 99 Years
Eligibility Inclusion Criteria: - isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) Exclusion Criteria: - below 65 years of age - coronary revascularization within 4 months before the index procedure - concomitant heart surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Aortic Valve Replacement
Aortic Valve Replacement (surgically or TAVI)

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Medical University of Vienna Landesklinikum Sankt Polten, Sicknessfund Burgenland

Outcome
Type Measure Description Time frame Safety issue
Primary all-cause mortality all cause mortality after aortic valve replacement 10 years
Secondary reoperation incidence of reoperation after aortic valve replacement 10 years
Secondary myocardial infaction incidence of myocardial infaction after aortic valve replacement 10 years
Secondary heart failure incidence of heart failure after aortic valve replacement 10 years
Secondary stroke incidence of stroke after aortic valve replacement 10 years
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