Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia
Roma, 00168, Italy
Location status: Recruiting
Location contact
Annalisa Pasquini, MD, PhD
CONTACT
Annalisa Pasquini, MD. PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06797687
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Roma, 00168, Italy
Location status: Recruiting
Annalisa Pasquini, MD, PhD
CONTACT
Annalisa Pasquini, MD. PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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
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).
Contact information is provided by the study sponsor or research team.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Mitral Valve Annulus Assessment, a Comparison Between 3D-TOE, CCT and Surgical Ring
Acronym: MAS-3D
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