NCT06153563

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

January 6, 2025

Status Verified

January 1, 2025

Enrollment Period

3.4 years

First QC Date

November 23, 2023

Last Update Submit

January 3, 2025

Conditions

Mitral Valve Disease

Keywords

Mitral valvemitral valve chordselasticityYoung's modulusmitral valve histology

Outcome Measures

Primary Outcomes (1)

  • Maximum value of Young's modulus

    Comparison of elasticity difference between the two groups

    Hour 1

Secondary Outcomes (1)

  • First histological evaluation

    Hour 1

Study Arms (2)

Mitral valve prolapse

Patients with mitral valve prolapse

Other: 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.

Interventions

Data collection on patient history and intraoperative results.OTHER

Data collection on patient history and intraoperative results.

Mitral valve prolapseRestrictive ischemic mitral valve

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients programmed for mitral valve replacement who have more than 45 years old

You may not qualify if:

  • Patients with mitral calcification
  • Mitral valve rheumatic disease
  • Mitral valve infections
  • Redo surgery on the mitral valve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, 42000, France

RECRUITING

Study Officials

  • Andranik PETROSYAN, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andranik PETROSYAN, MD

CONTACT

(0)477829505andranik.petrosyan@chu-st-etienne.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2023

First Posted

December 1, 2023

Study Start

October 18, 2021

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

January 6, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)