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Recruiting NCT06153563

Evaluation of the Elasticity of the Mitral Valve

Observational Mitral Valve Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection on patient history and intraoperative results..
Who it may be relevant to
Registry conditions: Mitral Valve Disease. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Data collection on patient history and intraoperative results.
    Data collection on patient history and intraoperative results.

Primary outcome measures

  • Maximum value of Young's modulus [Time frame: Hour 1]
Secondary outcome measures (1)
  • First histological evaluation [Time frame: Hour 1]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHU Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT06153563 · IRBN1102022/CHUSTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗