Mitral Valve DiseaseNCT05724537
Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
An observational study of Mitral Valve Disease, run by Michele De Bonis at 1 site in Italy.
Trial summary
Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Disease
- What is being tested?
- Quadrangular resection and annular plication
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2019to 15 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients affected by degenerative MR, due to prolapse/flail of the posterior leaflet, treated with quadrangular resection of the posterior leaflet and annular plication
Who may be able to join
- Adult patients
- Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation
- Treated with quadrangular resection of the posterior leaflet and annulus plication
Who cannot join
- Other patients
Trial locations and contacts
1 site in 1 country.
About this study
Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.
- Conditions
- Mitral Valve Disease
- Being tested
- Quadrangular resection and annular plication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrangular resection and annular plicationProcedure or surgery
Mitral regurgitation is treated removing the redundant tissue of the posterior leaflet, which is then reconstructed by sutures and plicating the posterior annulus
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start23 Feb 2019
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
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.
- 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
- Cross-sectional
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele De Bonis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele De Bonis, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724537
- Sponsor's protocol ID
- DURQUAP 2017
- Status last verified
- Feb 2023
- First submitted
- 30 Jan 2023
- Last updated
- 13 Feb 2023
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durability at 20 Years of Quadrangular Resection With Annular Plication for Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT05724537
- Acronym / sponsor ID
- DURQUAP 2017
- Conditions
- Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 23 Feb 2019 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 13 Feb 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.
Degenerative mitral regurgitation (MR) due to prolapse of the posterior leaflet is the most common dysfunction of the mitral valve (MV) in the Western world and is nowadays treated with a variety of surgical techniques. Quadrangular resection combined with annular plication and annuloplasty, as originally described by Carpentier, has been the standard approach for many years, before sliding/folding plasty and artificial chordae gained larger popularity.However, very few studies have been published on thevery long-term results (up to 20 years) of quadrangular resection and annular plication, often reporting only freedom from reoperation rather than from recurrent MR. This study aims to evaluate the very long-term (20 years) clinical and echocardiographic results of this approach, which was used for many years at the beginning of our mitral repair program.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by degenerative MR, due to prolapse/flail of the posterior leaflet, treated with quadrangular resection of the posterior leaflet and annular plication
Key inclusion criteria (3 listed)
- Adult patients
- Affected by mitral valve posterior leaflet prolapse/flail causing severe mitral regurgitation
- Treated with quadrangular resection of the posterior leaflet and annulus plication
Key exclusion criteria (1 listed)
- Other patients
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 |
|---|---|---|
| Quadrangular resection and annular plicationMitral regurgitation is treated removing the redundant tissue of the posterior leaflet, which is then reconstructed by sutures and plicating the posterior annulus | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: Up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Michele De Bonis at 1 site in Italy.
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 1 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: finished, as of the sponsor's last update on 13 Feb 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Up to 20 years). 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 13 Feb 2023.