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

NCT05714228 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2645

Last updated 2023-02-06

No results posted yet for this study

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

  • Mitral Valve Regurgitation

Interventions

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

Sponsors & Collaborators

  • Michele De Bonis

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2020-06-10
Completion
2020-06-10

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05714228 on ClinicalTrials.gov