Degenerative Mitral Valve DiseaseNCT05839782
Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
An observational study of Degenerative Mitral Valve Disease, run by Michele De Bonis at 1 site in Italy.
Trial summary
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Mitral Valve Disease
- What is being tested?
- Mitral valve repair (PLM) and Mitral valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 108 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 with a failure of mitral valve repair. The patients are divided in 2 groups depending on type of reintervention: a new mitral valve repair (PLM) or mitral valve replacement (SVM)
Who may be able to join
- adult patients
- failure of previous mitral valve repair which needed a new surgical treatment
- group Re-PLM: patients reoperated with a new mitral valve repair
- group Re-SVM: patients reoperated with a mitral valve replacement
Who cannot join
- urgent/emergent procedures
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Ospedale San Raffaele - Cardiac Surgery Department
Milan, 20132
About this study
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.
However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.
Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.
- Conditions
- Degenerative Mitral Valve Disease
- Being tested
- Mitral valve repair (PLM), Mitral valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitral valve repair (PLM)Procedure or surgery
A mitral valve plasty is performed to treat mitral regurgitation
Mitral valve replacementProcedure or surgery
A mitral valve replacement with a prosthesis is performed to treat mitral regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Re-PLM | Patient in which a new mitral valve repair is performed to treat failed mitral valve repair Receives: Procedure: Mitral valve repair (PLM) | |
| Re-SVM | Patient in which a mitral valve replacement is performed to treat failed mitral valve repair Receives: Procedure: Mitral valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival after reintervention
Time of survival after reintervention for failed mitral valve repair
Measured: through study completion, a minimum of 2 years
Secondary outcomes (1)
Risk factors for reintervention
Identification of predictors of reintervention after mitral valve repair
Measured: through study completion, a minimum of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 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 Degenerative 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
- 108 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
- NCT05839782
- Sponsor's protocol ID
- LORESAR
- Status last verified
- Apr 2023
- First submitted
- 27 Jan 2023
- Last updated
- 3 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results in Redo Mitral Valve Surgery After Mitral Valve Repair
- ClinicalTrials.gov ID
- NCT05839782
- Acronym / sponsor ID
- LORESAR
- Conditions
- Degenerative Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 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
- 3 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.
The current gold standard for severe mitral regurgitation is mitral valve plasty (PLM). The surgery allows the repair of the mitral valve, therefore without the need for mitral valve replacement (SVM), which involves the implantation of a biological prosthesis or a mechanical prosthesis.
However, PLM has a rate of failure, between 1-4% per year in degenerative mitral pathologies. As a result, patients with PLM failure and severe residual regurgitation are increasingly presenting in recent years.
Generally these patients are re-operated to replace the mitral valve. Our aim is to investigate the differences in re-operation involving mitral valve replacement or re-repair in patients who underwent mitral valve re-operation (re-repair or replacement) in our center between 2003 and 2017.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Re-PLM | – | Procedure: Mitral valve repair (PLM)Patient in which a new mitral valve repair is performed to treat failed mitral valve repair |
| Re-SVM | – | Procedure: Mitral valve replacementPatient in which a mitral valve replacement is performed to treat failed mitral valve repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a failure of mitral valve repair. The patients are divided in 2 groups depending on type of reintervention: a new mitral valve repair (PLM) or mitral valve replacement (SVM)
Key inclusion criteria (4 listed)
- adult patients
- failure of previous mitral valve repair which needed a new surgical treatment
- group Re-PLM: patients reoperated with a new mitral valve repair
- group Re-SVM: patients reoperated with a mitral valve replacement
Key exclusion criteria (1 listed)
- urgent/emergent procedures
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 repair (PLM)A mitral valve plasty is performed to treat mitral regurgitation | Procedure or surgery | Re-PLM |
| Mitral valve replacementA mitral valve replacement with a prosthesis is performed to treat mitral regurgitation | Procedure or surgery | Re-SVM |
Primary outcome
Survival after reintervention
Time frame: through study completion, a minimum of 2 years
Time of survival after reintervention for failed mitral valve repair
1 secondary outcome
Risk factors for reintervention
Time frame: through study completion, a minimum of 2 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 3 May 2023.
- Individual participant dataSharing planned: No
Related trials for Degenerative Mitral Valve Disease
Recruiting
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Mitral Valve Regurgitation (Degenerative or Functional)
Not yet recruiting
Anchord Mitral Chordal Repair System - FIH
Mitral Regurgitation
Recruiting
ATLAS (AltaValve) Pivotal Trial
Mitral Regurgitation, Mitral Insufficiency
Active, not recruiting
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
Mitral Regurgitation, Mitral Insufficiency
Active, not recruiting
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Degenerative Mitral Valve Disease, Mitral Regurgitation
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 Degenerative 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 4 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 3 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?
Survival after reintervention (time frame: through study completion, a minimum of 2 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 3 May 2023.