Mitral RegurgitationNCT05836480
Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
An observational study of Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
Trial summary
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2019to 15 Oct 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 who underwent surgical mitral valve repair. Patients of study (Suboptimal) group were discharged with a 2+ or more residual mitral regurgitation, patients in control group (Optimal) were discharged with a 1+ or less residual mitral regurgitation
Who may be able to join
- Study group:
- presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
- presence of moderate residual mitral regurgitation at discharge.
- Control group:
- presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
- presence of residual mitral regurgitation of at least mild grade at discharge.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.
Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).
The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study
- Conditions
- Mitral Regurgitation
- Being tested
- mitral valve repair
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitral valve repairProcedure or surgery
conservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique
| Study group | Role | What they receive |
|---|---|---|
| Suboptimal repair | Patients discharged with a residual mitral regurgitation of at least moderate (2+)degree Receives: Procedure: mitral valve repair | |
| Optimal repair | Patients discharged with a residual mitral regurgitation of mild (1+) or less degree (trace or 0) Receives: Procedure: mitral valve repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: through study completion, a minimum of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 Oct 2019
- Primary completion15 Oct 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 141 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
- NCT05836480
- Sponsor's protocol ID
- SUB-MVR
- Status last verified
- Apr 2023
- First submitted
- 27 Jan 2023
- Last updated
- 1 May 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 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Suboptimal Result of Mitral Valve Repair: Late Implications in a Matched Cohort Study
- ClinicalTrials.gov ID
- NCT05836480
- Acronym / sponsor ID
- SUB-MVR
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 1 May 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.
Mitral valve regurgitation is a pathology affecting the left atrioventricular valve, conditioning the loss of the normal unidirectionality of the atrioventricular flow and therefore volumetric and pressure overload of the left heart chambers. In industrialized countries, the most common etiology of mitral regurgitation is degenerative mitral disease.
Mitral valve repair surgery represents the gold standard for the treatment of severe degenerative mitral regurgitation. The expected optimal result would be the absence of residual post-procedural mitral regurgitation, even if it is not uncommon to obtain a valve with residual regurgitation of a mild degree. In some cases, for various reasons (technical difficulties, long aortic clamping time, advanced age, high pre-operative surgical risk), a suboptimal result is accepted, i.e. a post-procedural residual mitral regurgitation of even a moderate degree ( 0, 1+, or 2+/4+).
The aim of the present study is to evaluate the late clinical and echocardiographic implications of suboptimal mitral valve repair with a paired-data cohort study
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suboptimal repair | – | Procedure: mitral valve repairPatients discharged with a residual mitral regurgitation of at least moderate (2+)degree |
| Optimal repair | – | Procedure: mitral valve repairPatients discharged with a residual mitral regurgitation of mild (1+) or less degree (trace or 0) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent surgical mitral valve repair. Patients of study (Suboptimal) group were discharged with a 2+ or more residual mitral regurgitation, patients in control group (Optimal) were discharged with a 1+ or less residual mitral regurgitation
Key inclusion criteria (6 listed)
- Study group:
- presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
- presence of moderate residual mitral regurgitation at discharge.
- Control group:
- presence of severe degenerative mitral regurgitation treated by mitral valve repair between 2006 and 2013;
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| mitral valve repairconservative surgery to treat mitral regurgitation. A mitral valve plasty is performed according to the most appropriate technique | Procedure or surgery | Optimal repair, Suboptimal repair |
Primary outcome
Mortality
Time frame: through study completion, a minimum of 6 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 1 May 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 Regurgitation, 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 6 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 1 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 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: through study completion, a minimum of 6 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 1 May 2023.