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

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: Aortic Valve Replacement

• Registration Number: NCT05912660
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-06
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-10
• Last Update Submitted: 2023-06-10
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18882

Inclusion Criteria

• isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI)

Read More

Exclusion Criteria

• below 65 years of age
• coronary revascularization within 4 months before the index procedure
• concomitant heart surgery

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aortic valve replacement with TAVI	Aortic Valve Replacement	-
Aortic valve replacement with surgically implanted bioprostheses	Aortic Valve Replacement	-

Primary Outcome Measures

Name	Time	Method
all-cause mortality	10 years	all cause mortality after aortic valve replacement

Secondary Outcome Measures

Name	Time	Method
stroke	10 years	incidence of stroke after aortic valve replacement
heart failure	10 years	incidence of heart failure after aortic valve replacement
myocardial infaction	10 years	incidence of myocardial infaction after aortic valve replacement
reoperation	10 years	incidence of reoperation after aortic valve replacement