Mitral RegurgitationNCT05836376
Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?
An observational study of Mitral Regurgitation, run by Michele De Bonis at 1 site in Italy.
Trial summary
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. 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 annuloplasty
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2020to 2 Dec 2020
- 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
- Adult, Older adult
Study population: Patients treated for functional mitral regurgitation with annuloplasty. Study group will comprehend patients with atrial functional mitral regurgitation, the control group will be of patients with non-atrial functional mitral regurgitation
Who may be able to join
None listed.
Who cannot join
- Degenerative MR including congenital clefts
- LVEF < 45%
- Ventricular tethering
- Coaptation depth >10 mm
- Regional abnormalities in left ventricular wall motion
- Sinus rhythm
Show all 15Show fewer
- Presence of coronary artery disease
- Absence of annular dilatation
- Non-atrial MR group Inclusion criteria
- Adult patients underwent cardiac surgery for non-atrial functional mitral regurgitation in the setting of an idiopathic or ischemic cardiomyopathy
- FE<40%
- Concomitant coronary artery bypass graft
- Age <65 years and >75years
- Treated with annuloplasty + edge-to-edge surgery
- Sinus rhythm
Trial locations and contacts
1 site in 1 country.
About this study
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken.
The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.
- Conditions
- Mitral Regurgitation
- Being tested
- Mitral valve annuloplasty
- 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 annuloplastyProcedure or surgery
implantation of a prosthetic ring to treat mitral valve regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Function Atrial MR | Not described Receives: Procedure: Mitral valve annuloplasty | |
| Functiona Non-atrial MR | Not described Receives: Procedure: Mitral valve annuloplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
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 start30 Nov 2020
- Primary completion2 Dec 2020
- Study completion2 Dec 2020
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
- 55 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
- NCT05836376
- Sponsor's protocol ID
- MAT-SAFMR
- 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
- Is Mitral Annuloplasty an Effective Treatment for Severe Atrial Functional MR?
- ClinicalTrials.gov ID
- NCT05836376
- Acronym / sponsor ID
- MAT-SAFMR
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 2 Dec 2020 (actual)
- Study completion
- 2 Dec 2020 (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.
Atrial functional mitral regurgitation (MR) is caused by annular dilatation and flattering associated with altered atria/annulus dynamics in patients with severely dilated left atrium and normal leaflets anatomy. Inadequate leaflets adaption is considered a mechanistic culprit as well. Prevalence of at least moderate atrial functional MR varies between 4.7% and 7% in patients with permanent and long standing persistent atrial fibrillation (AF) and is even higher in patients with Heart Failure with preserved Ejection Fraction (HFpEF). Unlike secondary MR in the setting of left ventricular disease, results of surgical treatment of severe atrial functional MR has remained largely unspoken.
The aim of this study is to analyze short and mid-term results of isolated annuloplasty in patients with severe, symptomatic atrial functional MR, in comparission to a matched cohort of patients with secondary MR.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Function Atrial MR | – | Procedure: Mitral valve annuloplasty |
| Functiona Non-atrial MR | – | Procedure: Mitral valve annuloplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated for functional mitral regurgitation with annuloplasty. Study group will comprehend patients with atrial functional mitral regurgitation, the control group will be of patients with non-atrial functional mitral regurgitation
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- Degenerative MR including congenital clefts
- LVEF < 45%
- Ventricular tethering
- Coaptation depth >10 mm
- Regional abnormalities in left ventricular wall motion
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 annuloplastyimplantation of a prosthetic ring to treat mitral valve regurgitation | Procedure or surgery | Function Atrial MR, Functiona Non-atrial MR |
Primary outcome
Mortality
Time frame: 30 days
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 0 inclusion and 15 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: 30 days). 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.