Evaluation of the Elasticity of the Mitral Valve

NCT ID: NCT06153563

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-18

Study Completion Date

2025-03-31

Brief Summary

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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

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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.

Conditions

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Mitral Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mitral valve prolapse

Patients with mitral valve prolapse

Data collection on patient history and intraoperative results.

Intervention Type OTHER

Data collection on patient history and intraoperative results.

Restrictive ischemic mitral valve

Patients with restrictive ischemic mitral valve

Data collection on patient history and intraoperative results.

Intervention Type OTHER

Data collection on patient history and intraoperative results.

Interventions

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Data collection on patient history and intraoperative results.

Data collection on patient history and intraoperative results.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andranik PETROSYAN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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CHU Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Andranik PETROSYAN, MD

Role: CONTACT

(0)477829505 ext. +33

Facility Contacts

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Andranik PETROSYAN, MD

Role: primary

(0)477829505 ext. +33

Other Identifiers

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IRBN1102022/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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