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Clinical Trial Summary

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.


Clinical Trial Description

This study is a clinical, single-center pilot-study to evaluate safety and performance. 30 Patients (n=20 aortic valve replacement/ n=10 mitral valve replacement) with aortic and mitral valve pathology, highly likely for prosthetic valve replacement, who are planned for surgery at the Vienna General Hospital (AKH) will be included in this study with respect to the inclusion and exclusion criteria. The patients will undergo aortic or prosthetic mitral valve replacement using a specified automated annular suturing system for placement of the annular pledgeted sutures. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04659655
Study type Interventional
Source Medical University of Vienna
Contact Martin Andreas, Assoc. Prof. PD MD MBA, PhD,
Phone +43 1 40400 52620
Email martin.andreas@meduniwien.ac.at
Status Recruiting
Phase N/A
Start date January 1, 2021
Completion date March 1, 2022

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