Evaluation of the Elasticity of the Mitral Valve

Recruiting

• Conditions: Mitral Valve Disease
• Interventions: Other: Data collection on patient history and intraoperative results.

• Registration Number: NCT06153563
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study Start: 2021-10-18
• Study First Submitted: 2023-11-23
• Study First Submitted QC: 2023-11-23
• Study First Posted: 2023-12-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mitral valve prolapse	Data collection on patient history and intraoperative results.	Patients with mitral valve prolapse
Restrictive ischemic mitral valve	Data collection on patient history and intraoperative results.	Patients with restrictive ischemic mitral valve

Primary Outcome Measures

Name	Time	Method
Maximum value of Young's modulus	Hour 1	Comparison of elasticity difference between the two groups

Secondary Outcome Measures

Name	Time	Method
First histological evaluation	Hour 1	Determine the histological characteristics of living humans

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France