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

June 10, 2023 updated by: Hendrik Jan Ankersmit, Medical University of Vienna
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

18882

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent isolated aortic valve replacement in Austria (surgically implanted bioprostheses or TAVI) above 65 years of age with no other concomitant heart surgery and no coronary revascularization within 4 months before the index procedure were included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality
Time Frame: 10 years
all cause mortality after aortic valve replacement
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reoperation
Time Frame: 10 years
incidence of reoperation after aortic valve replacement
10 years
stroke
Time Frame: 10 years
incidence of stroke after aortic valve replacement
10 years
myocardial infaction
Time Frame: 10 years
incidence of myocardial infaction after aortic valve replacement
10 years
heart failure
Time Frame: 10 years
incidence of heart failure after aortic valve replacement
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Collaborators

Landesklinikum Sankt Polten
Sicknessfund Burgenland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

June 10, 2023

First Submitted That Met QC Criteria

June 10, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 10, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTHEARTVISIT - TAVI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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