Trials / Completed
CompletedNCT05714228
Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,645 (actual)
- Sponsor
- Michele De Bonis · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgical Mitral Valve Repair | Mitral valve is repaired using open surgical approach |
| PROCEDURE | Transcatheter Mitral Valve Repair | Mitral valve is repaired using Mitraclip transcatheter device |
Timeline
- Start date
- 2020-06-10
- Primary completion
- 2020-06-10
- Completion
- 2020-06-10
- First posted
- 2023-02-06
- Last updated
- 2023-02-06
Locations
1 site across 1 country: Italy
Source: ClinicalTrials.gov record NCT05714228. Inclusion in this directory is not an endorsement.