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

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT05912660
• Collaborator: Sicknessfund Burgenland (Other), Landesklinikum Sankt Polten (Other)
• Enrollment: 18,882
• Actual Duration (Months): 132

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Disease	Device: Aortic Valve Replacement

Study Design

• Study Type: Observational
• Actual Enrollment: 18882 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Health Status of Patients After Surgically Implanted Biological and TAVI: a Population-based Retrospective Analysis
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Aortic valve replacement with surgically implanted bioprostheses	Device: Aortic Valve Replacement; Aortic Valve Replacement (surgically or TAVI)
Aortic valve replacement with TAVI	Device: Aortic Valve Replacement; Aortic Valve Replacement (surgically or TAVI)

Outcome Measures

Primary Outcome Measures

1. all-cause mortality [10 years]

   all cause mortality after aortic valve replacement

Secondary Outcome Measures

1. reoperation [10 years]

   incidence of reoperation after aortic valve replacement

2. myocardial infaction [10 years]

   incidence of myocardial infaction after aortic valve replacement

3. heart failure [10 years]

   incidence of heart failure after aortic valve replacement

4. stroke [10 years]

   incidence of stroke after aortic valve replacement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of Vienna
• Sicknessfund Burgenland
• Landesklinikum Sankt Polten

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hendrik Jan Ankersmit, Univ. Prof. , MD, MBA, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT05912660
• Other Study ID Numbers: AUTHEARTVISIT - TAVI
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Aortic Valve Disease

Study Results

No Results Posted as of Jun 22, 2023