Mitral Valve ProlapseIPPVMNCT03113552
Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
An observational study of Mitral Valve Prolapse and Mitral Plasty, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse, Mitral Plasty
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2013to 4 Jul 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study of the long-term survival of patients who have had mitral valve prolapse for mitral valve prolapse in Amiens according to the location of the prolapse
Who may be able to join
- Patients operated between 1988 and 2011
- Presence of a valvular prolapse diagnosed by echocardiography
- Possibility of a complete clinical evaluation at the time of the initial echocardiography
Who cannot join
- Ischemic MI (including papillary muscle rupture)
- Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease
- History of cardiac surgery
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 Amiens Picardie
Amiens, Picardie, 80054
Catherine SZYMANSKI, Dr, +33322455885, szymanski.catherine@chu-amiens.fr
About this study
Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.
- Conditions
- Mitral Valve Prolapse, Mitral Plasty
- Medical subject headings
- Mitral Valve Prolapse
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival defines as the time between the date of surgery and the death or date of the last news
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start4 Feb 2013
- Primary completion4 Jul 2028 (estimated)
- Study completion4 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113552
- Sponsor's protocol ID
- PI2013_843_0002
- Acronym
- IPPVM
- Status last verified
- Feb 2023
- First submitted
- 10 Apr 2017
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of the Location of Mitral Valve Prolapse on the Long-term Results of Mitral Plasty
- ClinicalTrials.gov ID
- NCT03113552
- Acronym / sponsor ID
- IPPVM / PI2013_843_0002
- Conditions
- Mitral Valve Prolapse, Mitral Plasty
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 Feb 2013 (actual)
- Primary completion
- 4 Jul 2028 (estimated)
- Study completion
- 4 Jul 2028 (estimated)
- First posted
- 13 Apr 2017 (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.
Mitral insufficiency (MI) accounts for 24% of adult valvulopathies and affects 7% of subjects older than 75 years. They are the second leading cause of valvulopathy in Europe. The most common etiology is the associated valvular prolapse. Mitral surgery remains the reference treatment for symptomatic MI. The success of this procedure depends on the mitral valve geometry and the location of the prolapse. The site of the prolapse, whether monovalvular, localized to the posterior or anterior leaflet, or bivalvular, influences the possibilities and probably the long-term results of the plasty.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study of the long-term survival of patients who have had mitral valve prolapse for mitral valve prolapse in Amiens according to the location of the prolapse
Key inclusion criteria (3 listed)
- Patients operated between 1988 and 2011
- Presence of a valvular prolapse diagnosed by echocardiography
- Possibility of a complete clinical evaluation at the time of the initial echocardiography
Key exclusion criteria (3 listed)
- Ischemic MI (including papillary muscle rupture)
- Presence of significant aortic valvulopathy, mitral valvular stenosis or congenital disease
- History of cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival defines as the time between the date of surgery and the death or date of the last news
Time frame: 6 months
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 23 May 2023.
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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.
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 Prolapse and Mitral Plasty, run by Centre Hospitalier Universitaire, Amiens 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 3 inclusion and 3 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 23 May 2023. 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 Catherine SZYMANSKI, Dr (+33322455885, szymanski.catherine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival defines as the time between the date of surgery and the death or date of the last news (time frame: 6 months). 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 23 May 2023.