Health Status of Patients After Surgically Implanted Biol... | NCT04900909

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Dec 31, 2018Actual

First Submitted Date

May 20, 2021

First Submission Date that Met QC Criteria

May 20, 2021

First Posted Date

May 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2022

Last Update Posted Date

Nov 18, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hendrik Jan Ankersmit, Principal Investigator/Univ. Prof. , MD, MBA, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Name	Class
Landesklinikum Sankt Polten	OTHER
Sicknessfund Burgenland (BGKK)	UNKNOWN
A.ö. Krankenhaus St. Josef Braunau GmbH	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

13,993Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Aortic valve replacement with mechanical valves			Device: Aortic Valve Replacement
Aortic valve replacement with bioprostheses			Device: Aortic Valve Replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Aortic Valve Replacement	Device	Surgical replacement of aortic valves	Aortic valve replacement with bioprostheses Aortic valve replacement with mechanical valves

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall mortality	all cause mortality after aortic valve replacement	8 years

Secondary Outcomes

Measure	Description	Time Frame
reoperation	incidence of reoperation after aortic valve replacement	8 years
stroke	incidence of stroke after aortic valve replacement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

below 18 years of age
concomitant heart surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years of age with no other concomitant heart surgery were included.

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D019918	Heart Valve Prosthesis Implantation
D006348	Cardiac Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019919	Prosthesis Implantation
D019616	Thoracic Surgical Procedures