Evaluation of the Elasticity of the Mitral Valve | NCT06153563

Studies
Evaluation of the Elasticity of the Mitral Valve

NCT06153563

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Recruiting

Last Update Posted

Jan 6, 2025Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Mitral Valve Disease

Interventions

Data collection on patient history and intraoperative results.

Countries

France

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 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 18, 2021Actual

Primary Completion Date

Mar 2025Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Nov 23, 2023

First Posted Date

Dec 1, 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 3, 2025

Last Update Posted Date

Jan 6, 2025Actual

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

There is no information in the literature on the mechanobiological characteristics of mitral valve chords in living humans. All examinations were carried out on tissues taken from animals, either from cadavers or from frozen human tissues. The objective is to determine mechanobiological and histological characteristics of the mitral valve chords in living humans, as well as to compare differences in elasticity in different groups (Group A: patients with mitral valve prolapse versus Group B: patients with restrictive ischemic mitral valve).

Detailed Description

The prospective study will be conducted on 20 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

The harvested tissue will not be frozen and will kept in natural conditions as close as possible.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mitral valve prolapse		Patients with mitral valve prolapse	Other: Data collection on patient history and intraoperative results.
Restrictive ischemic mitral valve		Patients with restrictive ischemic mitral valve	Other: Data collection on patient history and intraoperative results.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Data collection on patient history and intraoperative results.	Other	Data collection on patient history and intraoperative results.	Mitral valve prolapse Restrictive ischemic mitral valve

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum value of Young's modulus	Comparison of elasticity difference between the two groups	Hour 1

Secondary Outcomes

Measure	Description	Time Frame
First histological evaluation	Determine the histological characteristics of living humans	Hour 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients programmed for mitral valve replacement who have more than 45 years old

Exclusion Criteria:

Patients with mitral calcification
Mitral valve rheumatic disease
Mitral valve infections
Redo surgery on the mitral valve

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients programmed for mitral valve replacement who have more than 45 years old

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andranik PETROSYAN, MD	Contact	(0)477829505	+33	andranik.petrosyan@chu-st-etienne.fr

Overall Officials

Name	Affiliation	Role
Andranik PETROSYAN, MD	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Saint-Etienne	Recruiting	Saint-Etienne		42000	France

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