Mitral RegurgitationMAS-3DNCT06797687
Mitral Valve Annulus Assessment, Multimodality Imaging
An observational study of Mitral Regurgitation, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The success of mitral valve repair with annuloplasty depends on the repair technique and on the choice of a ring with appropriate dimensions related to mitral annulus. Intraoperatively, the choice of the prosthetic ring size is made by the surgeon using special gauges that are placed on the anterior mitral leaflet… 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?
- Cardiac computed tomography
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 15 Mar 2025to 15 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 severe mitral regurgitation with indication to surgical treatment who are elegible according to inclusion and exclusion criteria
Who may be able to join
- Patients aged 18 years or older
- Patients with severe mitral valve regurgitation, with an indication for surgical treatment of the valvopathy and who have undergone cardiac surgery for mitral valve surgery with prosthetic ring implantation
- Pre-operative coronary CT scan as a diagnostic tool for the exclusion of coronary artery disease (in accordance with the guidelines for chronic coronary syndrome and valvulopathy) with adequate image quality to allow measurement of the mitral annulus
- Availability of adequate three-dimensional echocardiographic reconstructions of the mitral valve apparatus at the intraoperative transesophageal echocardiogram to allow measurements of the annulus
- Provision of informed consent prior to enrolment
Who cannot join
- Implantation of mitral valve prosthesis due to inability to perform mitral valve repair
- Unavailability of CCT scan
- Unavailability of intraoperative transesophageal echocardiogram
- Unavailability of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia
Roma, 00168
Annalisa Pasquini, MD, PhD, +390630155701, annalisa.pasquini@policlinicogemelli.it
Annalisa Pasquini, MD. PhD
About this study
Official title: Mitral Valve Annulus Assessment, a Comparison Between 3D-TOE, CCT and Surgical Ring
The success of mitral valve repair with annuloplasty depends on the repair technique and on the choice of a ring with appropriate dimensions related to mitral annulus. Intraoperatively, the choice of the prosthetic ring size is made by the surgeon using special gauges that are placed on the anterior mitral leaflet (having the trigons and commissures as anatomical findings), a method considered the gold standard for defining annulus size. However, it is performed in cardioplegia, without considering annulus shape and motion during cardiac cycle. Three-dimensional techniques are fundamental in evaluating mitral valve structure and its changes during cardiac cycle; three-dimensional transoesophageal echocardiography (3D-TOE) has been proven to be essential for the anatomo-functional characterization of mitral valve apparatus in patients undergoing surgically mitral valve repair. It also allows the measurement of quantitative parameters useful in determining the size of the annuloplasty ring, such as A2 scallop height, intertrigonal distance, intercommissural diameter and total annular perimeter size, that will support the surgeon's choice on the dimensions of the ring to be implanted. Cardiac computed tomography (CCT) plays a key role for device sizing in patients undergoing transcatheter mitral valve replacement; it provides isotropic sub-millimetre spatial resolution and it is the gold standard for geometric characterisation of the mitral valve and for assessment of the spatial relationship of mitral valve apparatus to adjacent anatomical structures. In patients undergoing mitral valve surgery it is foremost performed to exclude coronary artery disease, as stated by European Society of Cardiology (ESC) guidelines. Several studies have compared CCT with 3D-TOE in sizing the mitral valve apparatus: Shanks et al. have demonstrated a good correlation between the two techniques in measuring intercommissural diameter; Hirasawa et al. have demonstrated a good correlation in evaluating intertrigonal distance. Only one study has compared the measures of the annulus obtained by CCT with the prosthetic ring (Alkhadi et al.) and only for 9 patients the intercommissural diameter was compared to the prosthetic ring, obtaining a good correlation.
- Conditions
- Mitral Regurgitation
- Being tested
- Cardiac computed tomography
- 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.
Cardiac computed tomographyDiagnostic test
Also called Three-dimensional transesophageal echocardiography, Mitral valve surgical repair
Mitral valve annulus measurements in the enrolled patients obtained will be obtained from: coronary CT scan, intraoperative transesophageal echocardiography and the ring surgically implanted during surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison between 3D-TOE and CCT
The reliability of mitral annulus measurements obtained by three-dimensional transesophageal echocardiography (evaluated in terms of anterior leaflet length, intertrigonal distance and intercommissural diameter) compared to cardiac computed tomography.
Measured: 48 hours
Secondary outcomes (3)
Comparison between CCT and surgery
The reliability of mitral annulus measurements obtained by cardiac computed tomography with the dimensions of the implanted ring during cardiac mitral valve repair surgery.
Measured: 48 hours
Comparison between 3D-TOE and surgery
The reliability of mitral annulus measurements obtained by intraoperative three-dimensional transesophageal echocardiogram with the dimensions of the implanted ring during cardiac mitral valve repair surgery
Measured: 24 hours
Determination of the best measure
To demonstrate whether any of the individual variables (anterior leaflet height, intertrigonal distance and intercommissural diameter) correlates better with the size of the implanted ring size (from the available data, the intercommissural diameter has shown a better correlation than the intertrigonal distance, although there are no studies that have directly compared the two values).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start15 Mar 2025
- Primary completion15 Mar 2026 (estimated)
- Study completion15 May 2026 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annalisa Pasquini, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797687
- Sponsor's protocol ID
- 7065
- Acronym
- MAS-3D
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitral Valve Annulus Assessment, a Comparison Between 3D-TOE, CCT and Surgical Ring
- ClinicalTrials.gov ID
- NCT06797687
- Acronym / sponsor ID
- MAS-3D / 7065
- Conditions
- Mitral Regurgitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 28 Jan 2025 (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 success of mitral valve repair with annuloplasty depends on the repair technique and on the choice of a ring with appropriate dimensions related to mitral annulus. Intraoperatively, the choice of the prosthetic ring size is made by the surgeon using special gauges that are placed on the anterior mitral leaflet (having the trigons and commissures as anatomical findings), a method considered the gold standard for defining annulus size. However, it is performed in cardioplegia, without considering annulus shape and motion during cardiac cycle. Three-dimensional techniques are fundamental in evaluating mitral valve structure and its changes during cardiac cycle; three-dimensional transoesophageal echocardiography (3D-TOE) has been proven to be essential for the anatomo-functional characterization of mitral valve apparatus in patients undergoing surgically mitral valve repair. It also allows the measurement of quantitative parameters useful in determining the size of the annuloplasty ring, such as A2 scallop height, intertrigonal distance, intercommissural diameter and total annular perimeter size, that will support the surgeon's choice on the dimensions of the ring to be implanted. Cardiac computed tomography (CCT) plays a key role for device sizing in patients undergoing transcatheter mitral valve replacement; it provides isotropic sub-millimetre spatial resolution and it is the gold standard for geometric characterisation of the mitral valve and for assessment of the spatial relationship of mitral valve apparatus to adjacent anatomical structures. In patients undergoing mitral valve surgery it is foremost performed to exclude coronary artery disease, as stated by European Society of Cardiology (ESC) guidelines. Several studies have compared CCT with 3D-TOE in sizing the mitral valve apparatus: Shanks et al. have demonstrated a good correlation between the two techniques in measuring intercommissural diameter; Hirasawa et al. have demonstrated a good correlation in evaluating intertrigonal distance. Only one study has compared the measures of the annulus obtained by CCT with the prosthetic ring (Alkhadi et al.) and only for 9 patients the intercommissural diameter was compared to the prosthetic ring, obtaining a good correlation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe mitral regurgitation with indication to surgical treatment who are elegible according to inclusion and exclusion criteria
Key inclusion criteria (5 listed)
- Patients aged 18 years or older
- Patients with severe mitral valve regurgitation, with an indication for surgical treatment of the valvopathy and who have undergone cardiac surgery for mitral valve surgery with prosthetic ring implantation
- Pre-operative coronary CT scan as a diagnostic tool for the exclusion of coronary artery disease (in accordance with the guidelines for chronic coronary syndrome and valvulopathy) with adequate image quality to allow measurement of the mitral annulus
- Availability of adequate three-dimensional echocardiographic reconstructions of the mitral valve apparatus at the intraoperative transesophageal echocardiogram to allow measurements of the annulus
- Provision of informed consent prior to enrolment
Key exclusion criteria (4 listed)
- Implantation of mitral valve prosthesis due to inability to perform mitral valve repair
- Unavailability of CCT scan
- Unavailability of intraoperative transesophageal echocardiogram
- Unavailability of informed consent
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 |
|---|---|---|
| Cardiac computed tomographyAlso: Three-dimensional transesophageal echocardiography, Mitral valve surgical repairMitral valve annulus measurements in the enrolled patients obtained will be obtained from: coronary CT scan, intraoperative transesophageal echocardiography and the ring surgically implanted during surgery. | Diagnostic test | – |
Primary outcome
Comparison between 3D-TOE and CCT
Time frame: 48 hours
The reliability of mitral annulus measurements obtained by three-dimensional transesophageal echocardiography (evaluated in terms of anterior leaflet length, intertrigonal distance and intercommissural diameter) compared to cardiac computed tomography.
3 secondary outcomes
Comparison between CCT and surgery
Time frame: 48 hours
Comparison between 3D-TOE and surgery
Time frame: 24 hours
Determination of the best measure
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
Related trials for Mitral Regurgitation
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
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.
Annalisa Pasquini, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Fondazione Policlinico Universitario Agostino Gemelli IRCCS 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 4 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: looking for participants now, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Pasquini, MD, PhD (+390630155701, annalisa.pasquini@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between 3D-TOE and CCT (time frame: 48 hours). 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 15 Aug 2025; AzTrials last refreshed its copy on 29 Oct 2026.