Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

• Sponsor: Medical University of Vienna (Other)
• Overall Status: Completed
• CT.gov ID: NCT04900909
• Collaborator: Landesklinikum Sankt Polten (Other), Sicknessfund Burgenland (BGKK) (Other), A.ö. Krankenhaus St. Josef Braunau GmbH (Other)
• Enrollment: 13,993
• Actual Duration (Months): 108

Study Details

Study Description

Brief Summary

The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.

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

Detailed Description

The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2018.

Study Design

• Study Type: Observational
• Actual Enrollment: 13993 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)
• Actual Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Dec 31, 2018
• Actual Study Completion Date: Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Aortic valve replacement with mechanical valves	Device: Aortic Valve Replacement; Surgical replacement of aortic valves
Aortic valve replacement with bioprostheses	Device: Aortic Valve Replacement; Surgical replacement of aortic valves

Outcome Measures

Primary Outcome Measures

1. Overall mortality [8 years]

   all cause mortality after aortic valve replacement

Secondary Outcome Measures

1. reoperation [8 years]

   incidence of reoperation after aortic valve replacement

2. stroke [8 years]

   incidence of stroke after aortic valve replacement

3. heart attack [8 years]

   incidence of heart attack after aortic valve replacement

4. heart insufficiency [8 years]

   incidence of heart insufficiency after aortic valve replacement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

• below 18 years of age

• concomitant heart surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Medical University of Vienna
• Landesklinikum Sankt Polten
• Sicknessfund Burgenland (BGKK)
• A.ö. Krankenhaus St. Josef Braunau GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hendrik Jan Ankersmit, Principal Investigator/Univ. Prof. , MD, MBA, Medical University of Vienna
• ClinicalTrials.gov Identifier: NCT04900909
• Other Study ID Numbers: AUTHEARTVISIT
• First Posted: May 25, 2021
• Last Update Posted: May 27, 2021
• Last Verified: May 1, 2021

• 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 May 27, 2021