Validation of the EuroSCORE II in Open and Trans-catheter Mitral Valve Repair.
NCT ID: NCT05714228
Last Updated: 2023-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2645 participants
OBSERVATIONAL
2020-06-10
2020-06-10
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Surgical repair
Surgical Mitral Valve Repair
Mitral valve is repaired using open surgical approach
Transcatheter repair
Transcatheter Mitral Valve Repair
Mitral valve is repaired using Mitraclip transcatheter device
Interventions
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Surgical Mitral Valve Repair
Mitral valve is repaired using open surgical approach
Transcatheter Mitral Valve Repair
Mitral valve is repaired using Mitraclip transcatheter device
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing transcatheter mitral valve repair with MitraClip implantation
* Patients operated on at the U.O. of Cardiac Surgery at the San Raffaele Hospital from January 2012 to December 2019
Exclusion Criteria
* Cardiac surgery patients not eligible for mitral valve surgery
* Patients undergoing mitral implantation, both open and transcatheter, of devices in experimental clinical study (e.g., but not limited to, adjustable rings and neocords, etc.)
18 Years
ALL
No
Sponsors
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Michele De Bonis
OTHER
Responsible Party
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Michele De Bonis
Chief of Cardiac Surgery of Advanced and Research Therapies
Locations
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IRCCS Ospedale San Raffaele
Milan, , Italy
Countries
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Other Identifiers
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VEOT-MVR
Identifier Type: -
Identifier Source: org_study_id
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