Mitral valve annulus sizing with cardiac CT and 3D transesophageal echocardiography

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

This project will test whether preoperative cardiac CT and intraoperative 3D transesophageal echocardiography can provide mitral annulus measurements that match the surgeon's ring sizing for adults with severe mitral regurgitation undergoing repair.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Locations: 1 site (Roma)
• Trial ID: NCT06797687 on ClinicalTrials.gov

What this trial studies

Surgeons traditionally select annuloplasty ring size intraoperatively using physical gauges placed on the anterior mitral leaflet under cardioplegia, which ignores annular shape and motion during the cardiac cycle. This observational protocol will compare quantitative mitral annulus measurements obtained from preoperative cardiac CT and intraoperative 3D transesophageal echocardiography with the prosthetic ring sizes implanted at surgery in adults with severe mitral regurgitation. Eligible patients must have high-quality preoperative coronary CT suitable for annulus measurement and adequate intraoperative 3D-TOE reconstructions. The analysis will characterize modality differences across the cardiac cycle and explore whether imaging-derived metrics correspond to the surgeon's chosen ring size.

Who should consider this trial

Good fit: Adults (≥18 years) with severe mitral regurgitation scheduled for surgical repair with planned annuloplasty ring implantation who have preoperative coronary CT and adequate intraoperative 3D transesophageal echocardiography reconstructions and provide informed consent.

Not a fit: Patients who undergo valve replacement instead of repair, those without the required CT or intraoperative 3D-TOE imaging, or those with insufficient image quality are unlikely to benefit from the findings.

Why it matters

Potential benefit: If successful, imaging-guided sizing could improve preoperative planning and lead to better-matched annuloplasty rings, potentially improving repair durability and operative efficiency.

How similar studies have performed: Three-dimensional transesophageal echocardiography is established for anatomo-functional mitral characterization, but direct comparisons of CT and 3D-TOE measurements versus surgeon-selected ring sizes remain limited and are still being explored.

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

Where this trial is running

Roma

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Cardiologia — Roma, Italy (Recruiting)

Study contacts

• Principal investigator: Annalisa Pasquini, MD, PhD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Annalisa Pasquini, MD, PhD

Conditions Mitral Regurgitation