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
|
Aortic Valve Replacement (surgically or TAVI)
|
|
Aortic valve replacement with TAVI
|
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
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.