Evaluation of the Elasticity of the Mitral Valve

Evaluation of the Elasticity of the Mitral Valve Chordae by Uniaxial Traction in the Context of Mitral Valve Regurgitation With a Comparison of the Results: Mitral Valve Prolapse vs Restriction of Mitral Valve Movement

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).

Study Overview

• Status: Recruiting
• Conditions: Mitral Valve Disease
• Intervention / Treatment: Other: Data collection on patient history and intraoperative results.

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.

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Andranik PETROSYAN, MD; Phone Number: +33 (0)477829505; Email: andranik.petrosyan@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42000
    • Recruiting
    • CHU Saint-Etienne
    • Contact: Andranik PETROSYAN, MD; Phone Number: +33 (0)477829505; Email: andranik.petrosyan@chu-st-etienne.fr
    • Principal Investigator: Andranik PETROSYAN, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mitral valve prolapse; Patients with mitral valve prolapse	Other: Data collection on patient history and intraoperative results.; 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.; Data collection on patient history and intraoperative results.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Andranik PETROSYAN, MD, Chu Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 23, 2023
• First Submitted That Met QC Criteria: November 23, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 3, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Mitral valve; elasticity; mitral valve chords; Young's modulus; mitral valve histology
• Other Study ID Numbers: IRBN1102022/CHUSTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No