Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153563
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2023-11-23
Brief Title:
Evaluation of the Elasticity of the Mitral Valve
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
The harvested tissue will not be frozen and will kept in natural conditions as close as possible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None