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NCT Number: NCT06797687

Mitral Valve Annulus Assessment, Multimodality Imaging

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia

Roma, 00168, Italy

Location status: Recruiting

Location contact

Annalisa Pasquini, MD, PhD

CONTACT

[email protected]

+390630155701

Annalisa Pasquini, MD. PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Computed Tomography

Diagnostic Test

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.

Other names: Three-dimensional transesophageal echocardiography, Mitral valve surgical repair

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Annalisa Pasquini, MD, PhD

CONTACT

[email protected]

+390630155701

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Mitral Valve Annulus Assessment, a Comparison Between 3D-TOE, CCT and Surgical Ring

Acronym: MAS-3D

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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