Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-26 @ 10:36 AM
NCT ID:
NCT05714228
Brief 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.
Study:
NCT05714228
Study Brief:
Protocol Section:
NCT05714228