Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 3:12 PM
Study NCT ID:
NCT05714228
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2023-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Sponsor:
Michele De Bonis
Organization:
Study Overview
Official Title:
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: