Clinical trial NCT06797687: Mitral Valve Annulus Assessment, Multimodality Imaging
Official title: Mitral Valve Annulus Assessment, a Comparison Between 3D-TOE, CCT and Surgical Ring
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mitral Regurgitation
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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 (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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison between 3D-TOE and CCT
timeFrame: 48 hours
Secondary outcomes:
measure: Comparison between CCT and surgery
timeFrame: 48 hours
measure: Comparison between 3D-TOE and surgery
timeFrame: 24 hours
measure: Determination of the best measure
timeFrame: 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Annalisa Pasquini, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: