Mitral Valve Annulus Assessment, Multimodality Imaging (MAS-3D)

August 12, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Recruiting

Conditions

Mitral Regurgitation

Intervention / Treatment

Diagnostic test: Cardiac computed tomography

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Annalisa Pasquini, MD, PhD
Phone Number: +390630155701
Email: annalisa.pasquini@policlinicogemelli.it

Study Locations

Italy
- - Roma, Italy, 00168
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia
    - Contact:
      
      Annalisa Pasquini, MD, PhD
      
      Phone Number: +390630155701
      
      Email: annalisa.pasquini@policlinicogemelli.it
    - Principal Investigator:
      
      Annalisa Pasquini, MD. PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

patients with severe mitral regurgitation with indication to surgical treatment who are elegible according to inclusion and exclusion criteria

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the best measure Time Frame: 1 year	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).	1 year
Comparison between CCT and surgery Time Frame: 48 hours	The reliability of mitral annulus measurements obtained by cardiac computed tomography with the dimensions of the implanted ring during cardiac mitral valve repair surgery.	48 hours
Comparison between 3D-TOE and surgery Time Frame: 24 hours	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	24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Annalisa Pasquini, MD, PhD, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2025

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria