Mitral Valve DiseaseNCT06153563
Evaluation of the Elasticity of the Mitral Valve
An observational study of Mitral Valve Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Data collection on patient history and intraoperative results.
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2021to Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients programmed for mitral valve replacement who have more than 45 years old
Who may be able to join
- All patients programmed for mitral valve replacement who have more than 45 years old
Who cannot join
- Patients with mitral calcification
- Mitral valve rheumatic disease
- Mitral valve infections
- Redo surgery on the mitral valve
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne, 42000
Andranik PETROSYAN, MD, (0)477829505 ext. +33, andranik.petrosyan@chu-st-etienne.fr
Andranik PETROSYAN, MD
About this study
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
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).
Read the 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.
- Conditions
- Mitral Valve Disease
- Being tested
- Data collection on patient history and intraoperative results.
- Keywords
- Mitral valve, mitral valve chords, elasticity, Young's modulus, mitral valve histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection on patient history and intraoperative results.Other
Data collection on patient history and intraoperative results.
| Study group | Role | What they receive |
|---|---|---|
| Mitral valve prolapse | Patients with mitral valve prolapse Receives: Other: Data collection on patient history and intraoperative results. | |
| Restrictive ischemic mitral valve | Patients with restrictive ischemic mitral valve Receives: Other: Data collection on patient history and intraoperative results. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum value of Young's modulus
Comparison of elasticity difference between the two groups
Measured: Hour 1
Secondary outcomes (1)
First histological evaluation
Determine the histological characteristics of living humans
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start18 Oct 2021
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andranik PETROSYAN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153563
- Sponsor's protocol ID
- IRBN1102022/CHUSTE
- Status last verified
- Jan 2025
- First submitted
- 23 Nov 2023
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06153563
- Acronym / sponsor ID
- IRBN1102022/CHUSTE
- Conditions
- Mitral Valve Disease
- Keywords
- Mitral valve, mitral valve chords, elasticity, Young's modulus, mitral valve histology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mitral valve prolapse | – | Other: Data collection on patient history and intraoperative results.Patients with mitral valve prolapse |
| Restrictive ischemic mitral valve | – | Other: Data collection on patient history and intraoperative results.Patients with restrictive ischemic mitral valve |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients programmed for mitral valve replacement who have more than 45 years old
Key inclusion criteria (1 listed)
- All patients programmed for mitral valve replacement who have more than 45 years old
Key exclusion criteria (4 listed)
- Patients with mitral calcification
- Mitral valve rheumatic disease
- Mitral valve infections
- Redo surgery on the mitral valve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection on patient history and intraoperative results.Data collection on patient history and intraoperative results. | Other | Mitral valve prolapse, Restrictive ischemic mitral valve |
Primary outcome
Maximum value of Young's modulus
Time frame: Hour 1
Comparison of elasticity difference between the two groups
1 secondary outcome
First histological evaluation
Time frame: Hour 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andranik PETROSYAN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Disease, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andranik PETROSYAN, MD ((0)477829505 ext. +33, andranik.petrosyan@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum value of Young's modulus (time frame: Hour 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.