Degenerative Mitral Valve DiseaseNCT05774769
Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
An observational study of Degenerative Mitral Valve Disease, run by Michele De Bonis at 1 site in Italy.
Trial summary
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the… 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?
- Commissural edge to edge mitral valve repair
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 9 Oct 2021to 19 Oct 2021
- 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 degenerative mitral valve disease in whom regurgitation occurred in commissural position, hence were treated with a commisural edge to edge surgery
Who may be able to join
- Adult patients;
- Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
- Patients operated on with median sternotomy or left minithoracotomy;
- Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
- Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.
Who cannot join
- Patients underwent a mitral valve replacement
Trial locations and contacts
1 site in 1 country.
About this study
Mitral regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.
- Conditions
- Degenerative Mitral Valve Disease
- Being tested
- Commissural edge to edge mitral valve repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commissural edge to edge mitral valve repairProcedure or surgery
Edge to edge is the suture of mitral valve leaflets tissue in the regurgitant spot. If the regurgitant jet is near a mitral commissure, it is called a commissural edge to edge.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: Through study completion, an average of 14,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start9 Oct 2021
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
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
- 125 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
- NCT05774769
- Sponsor's protocol ID
- COSMIR
- Status last verified
- Mar 2023
- First submitted
- 30 Jan 2023
- Last updated
- 20 Mar 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time.
- ClinicalTrials.gov ID
- NCT05774769
- Acronym / sponsor ID
- COSMIR
- Conditions
- Degenerative Mitral Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 20 Mar 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 regurgitation (MR) for degenerative disease is nowadays routinely treated with valve repair with excellent short and long term results in experienced centers. However, repair durability can varies according to the characteristics of the initial lesion, and better long term durability in isolated lesions of the posterior leaflets compared to anterior or bi-leaflets prolapse has been shown. A commissural MR can be caused by lesions of the anterior, posterior or both leaflets and several surgical techniques have been proposed to treat these lesions. However, long term outcomes of mitral valve repair (MVr) for isolated commissural flail or prolapse remain poor defined. In San Raffaele Hospital cardiac surgery, commissural lesions are usually treated with a functional approach, by means of edge-to-edge approximation of the anterior and posterior leaflet at the commissural area (commissural closure). The investigators previously reported the short and mid-term outcomes of this technique with satisfactory results. With this study the investigators aim to analyze the very long term clinical and echocardiographic results of isolated commissural lesions treated with commissural closure.
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 with a degenerative mitral valve disease in whom regurgitation occurred in commissural position, hence were treated with a commisural edge to edge surgery
Key inclusion criteria (5 listed)
- Adult patients;
- Patients underwent mitral valve repair for flail or isolated commissural prolapse, of posterior, anterior or bileaflet origin;
- Patients operated on with median sternotomy or left minithoracotomy;
- Patients in whom the commissural MR has been treated with commissural closure and annuloplasty;
- Patients operated on at the Cardiac Surgery department of San Raffaele Hospital from January 1997 to December 2007.
Key exclusion criteria (1 listed)
- Patients underwent a mitral valve replacement
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 |
|---|---|---|
| Commissural edge to edge mitral valve repairEdge to edge is the suture of mitral valve leaflets tissue in the regurgitant spot. If the regurgitant jet is near a mitral commissure, it is called a commissural edge to edge. | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: Through study completion, an average of 14,5 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 20 Mar 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 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 5 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 20 Mar 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, an average of 14,5 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 20 Mar 2023.