Clinical Trials Logo
  1. Home
  2. Mitral Valve Disease
  3. NCT06153563
  4. Details
NCT06153563 Clinical Trial

Evaluation of the Elasticity of the Mitral Valve

Mitral Valve Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06153563
Other study ID # IRBN1102022/CHUSTE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 18, 2021
Est. completion date March 2024

Study information
Verified date November 2023
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Andranik PETROSYAN, MD
Phone (0)477829505
Email andranik.petrosyan@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date March 2024
Est. primary completion date March 2024
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
France CHU Saint-Etienne Saint-Étienne

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Maximum value of Young's modulus Comparison of elasticity difference between the two groups Hour 1
Secondary First histological evaluation Determine the histological characteristics of living humans Hour 1
See also
  Status Clinical Trial Phase
Completed NCT03283722 - PRESERVE-MITRAL Post-Market Registry
Not yet recruiting NCT06167213 - ALLIANCE Mitral: Safety and Effectiveness of SAPIEN X4 Transcatheter Heart Valve - Mitral N/A
Recruiting NCT06001489 - The Effects of 360-degree Virtual Reality on Pre-procedural Anxiety in Patients Awaiting Elective Cardiac Surgery Involving a Sternotomy N/A
Recruiting NCT06025149 - The Study on the Use of "UniLine" Bioprosthesis in the Treatment of Isolated Aortic and Mitral Valve Diseases
Completed NCT05193760 - Robustness Check of Placement and Measurement Algorithms for Blood Flow Measurement on Common Carotid Artery
Completed NCT05836558 - Are the Results of Minimally Invasive Mitral Valve Repair Still Satisfactory When Looked at Very Long-term?
Recruiting NCT05531253 - Respired Gases in Patients Post Cardiac Surgery
Completed NCT04045340 - Intraoperative Global Longitudinal Strain and Global Longitudinal Strain Rate as Predictors of Unfavorable Outcome in On-Pump Mitral Surgery
Active, not recruiting NCT04950192 - Philips Intracardiac Echocardiography (ICE) Clinical Registry
Recruiting NCT02925819 - Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Completed NCT03438825 - PRediction of Early PostoperAtive Right vEntricular Failure in Mitral Valve Replacement/Repair Patients
Completed NCT02000544 - Clinical Evaluation of a Modular Extracorporeal Circulation Circuit N/A
Recruiting NCT03574311 - Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery Phase 4
Active, not recruiting NCT03539458 - Feasibility Study of the Tendyne Mitral Valve System in Mitral Annular Calcification N/A
Recruiting NCT05898230 - Retrospective Clinical Data Collection on Carbomedics OptiForm Mitral Heart Valve
Withdrawn NCT01849757 - Comparison of Priming Constituents in Patients Undergoing CPB Assisted Cardiac Surgery: HES 130/0.4 or Albumin 5% N/A
Active, not recruiting NCT04147884 - A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation N/A
Completed NCT02097420 - HALO: A Single Arm Prospective Investigation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve N/A
Enrolling by invitation NCT04067635 - Primary Mitral Regurgitation Repair
Recruiting NCT04954404 - Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M) N/A