Clinical Trials Logo
  1. Home
  2. Aortic Valve Disease
  3. NCT04900909
  4. Details
NCT04900909 Clinical Trial

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

Aortic Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04900909
Other study ID # AUTHEARTVISIT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2010
Est. completion date December 31, 2018

Study information
Verified date November 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 13993
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - isolated surgical aortic valve replacement in Austria Exclusion Criteria: - below 18 years of age - concomitant heart surgery

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Aortic Valve Replacement
Surgical replacement of aortic valves

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Medical University of Vienna A.ö. Krankenhaus St. Josef Braunau GmbH, Landesklinikum Sankt Polten, Sicknessfund Burgenland (BGKK)

Outcome
Type Measure Description Time frame Safety issue
Primary Overall mortality all cause mortality after aortic valve replacement 8 years
Secondary reoperation incidence of reoperation after aortic valve replacement 8 years
Secondary stroke incidence of stroke after aortic valve replacement 8 years
Secondary heart attack incidence of heart attack after aortic valve replacement 8 years
Secondary heart insufficiency incidence of heart insufficiency after aortic valve replacement 8 years
See also
  Status Clinical Trial Phase
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Not yet recruiting NCT04430972 - Immune Responsiveness and Outcome After Aortic Valve Surgery (Measure)
Completed NCT02467062 - Implementation of Non-size Markers Derived From 4D Flow MRI of Patients With Aortic Disease. N/A
Not yet recruiting NCT02221921 - Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI N/A
Terminated NCT02128841 - Comparison of Antithrombotic Treatments After Aortic Valve Replacement. Rivaroxaban: A New Antithrombotic Treatment for Patients With Mechanical Prosthetic Aortic Heart Valve. Phase 2
Active, not recruiting NCT01194362 - A Study to Identify Differences in Gene Expression in Patients With Bicuspid and Tricuspid Valve Disease
Not yet recruiting NCT05975567 - Deploying Novel Imaging Modalities Towards a Three-dimensional (3D) CARDIOvascular PATHology
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05082337 - The SAVVY Guidewire in Transcatheter Aortic Valve Replacement Procedures N/A
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Not yet recruiting NCT05941455 - A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve N/A
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Active, not recruiting NCT03924661 - SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy
Completed NCT04073875 - 18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis
Recruiting NCT03121053 - Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement Phase 4
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Completed NCT02981004 - PAR I - Patient-to-Annulus Relation I
Completed NCT02688153 - EDWARDS INTUITY Valve System CADENCE Study N/A
Recruiting NCT06126367 - Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease/Aortic Valve Disease