Validation of the EuroSCORE II in Open and Trans-catheter... | NCT05714228

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

NCT05714228

Sponsor

Michele De Bonis

Status

Completed

Last Update Posted

Feb 6, 2023Actual

Enrollment

2,645Actual

Phase

Not provided

Conditions

Mitral Valve Regurgitation

Interventions

Surgical Mitral Valve Repair
Transcatheter Mitral Valve Repair

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2020Actual

Primary Completion Date

Jun 10, 2020Actual

Completion Date

Jun 10, 2020Actual

First Submitted Date

Jan 27, 2023

First Submission Date that Met QC Criteria

Jan 27, 2023

First Posted Date

Feb 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2023

Last Update Posted Date

Feb 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michele De Bonis, Chief of Cardiac Surgery of Advanced and Research Therapies, Ospedale San RaffaeleSponsor-Investigator

Lead Sponsor

Michele De BonisOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,645Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgical repair			Procedure: Surgical Mitral Valve Repair
Transcatheter repair			Procedure: Transcatheter Mitral Valve Repair

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgical Mitral Valve Repair	Procedure	Mitral valve is repaired using open surgical approach	Surgical repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Euroscore II overall predictive power		30 days postop
Euroscore II predictive power for surgery		30 days postop
Euroscore II predictive power for transcatheter		30 days postop

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent surgical or transcatheter mitral valve repair

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Ospedale San Raffaele		Milan		20132	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided