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Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.

Mitral Valve Regurgitation Clinical Trial

Official title:
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.

Clinical Trial Summary

The EuroSCORE II is widely used to predict 30-day mortality in patients undergoing open and trans-catheter cardiac surgery - However, it has not been validated in patients undergoing surgical or trans- catheter mitral valve repair. - The aim of this study is to evaluate the predictive value of the EuroSCORE II in estimating 30-day mortality in a large cohort of patients undergoing surgical and trans-catheter repair by means of Mitraclip implantation. Methods - Institutional database retrospective review for surgical mitral repair and MitraClip implantation. - Time frame: January 2012-December 2019 - 2793 patients identified; Euroscore II 1.3% [0.6%-2%] - Survival after hospital discharge was assessed by outpatients visit, usually done 2 months after the index procedure. Statistical analysis - Receiver operating characteristic (ROC) curves were used to determine the cut-offs of Euroscore II. ROC Area Under the Curve (AUC) values varies between 0 and 1, where 0.5 denotes a bad diagnostic test and 1 denotes an excellent diagnostic test. - The maximum Youden's Index (J=sensitivity + specificity - 1) was employed to define the optimal cut-point. - ROC curves were repeated for surgical and MitraClip patients separately, and for primary and secondary etiology as well.

Clinical Trial Description

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Study Design

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Clinical Trial Details
NCT number NCT05714228
Study type Observational
Source Ospedale San Raffaele
Contact
Status Completed
Phase
Start date June 10, 2020
Completion date June 10, 2020
View Details
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