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NCT Number: NCT06153563

Evaluation of the Elasticity of the Mitral Valve

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).

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Key information

Conditions

Mitral Valve Disease

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Saint-Etienne

Saint-Etienne, 42000, France

Location status: Recruiting

Location contact

Andranik PETROSYAN, MD

CONTACT

[email protected]

(0)477829505 ext. +33

Andranik PETROSYAN, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection on patient history and intraoperative results.

Other

Data collection on patient history and intraoperative results.

Primary outcomes

  1. Maximum value of Young's modulus

    Time frame: Hour 1

    Comparison of elasticity difference between the two groups

Secondary outcomes

  1. First histological evaluation

    Time frame: Hour 1

    Determine the histological characteristics of living humans

Study contacts

Contact information is provided by the study sponsor or research team.

Andranik PETROSYAN, MD

CONTACT

[email protected]

(0)477829505 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2023
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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