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Completed

NCT Number: NCT05714228

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

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.

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Key information

Conditions

Mitral Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undewent mitral valve repair with an open surgical approach, also in association with concomitant procedures (for example, but not limited to, aortic valve replacement, tricuspid repair, etc.)
  • 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

  • Patients underwent mitral valve replacement with prosthesis
  • 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.)

Treatment and study plan

Surgical Mitral Valve Repair

Procedure

Mitral valve is repaired using open surgical approach

Transcatheter Mitral Valve Repair

Procedure

Mitral valve is repaired using Mitraclip transcatheter device

Primary outcomes

  1. Euroscore II overall predictive power

    Time frame: 30 days postop

  2. Euroscore II predictive power for surgery

    Time frame: 30 days postop

  3. Euroscore II predictive power for transcatheter

    Time frame: 30 days postop

Sponsors and collaborators

Lead sponsor

Michele De Bonis

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2023
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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