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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: annalisa.pasquini@policlinicogemelli.it
• Phone: +390630155701

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Posterior Mitral Leaflet Replacement to Reduce Mitral Regurgitation

  This early feasibility trial tests the MR-ace Implant and Delivery System to see if it can reduce symptoms and leaks in people with moderate-to-severe functional mitral regurgitation.

  Recruiting Polares Medical SA · Atlanta, Georgia and 2 other locations · NCT07517588

• Replacing the native mitral valve with the ReValve System

  This study will test whether replacing the native mitral valve with the ReValve System helps adults with symptomatic, clinically significant mitral regurgitation who are appropriate candidates for mitral valve surgery.

  Recruiting at 3 sites Phase 1 ReValve Solutions Inc. · Tbilisi and 2 other locations · NCT07450911

• Mitral valve replacement with the SATURN TMVR system for severe mitral regurgitation

  This study tests whether the SATURN TS transcatheter mitral valve replacement can be safely implanted and work well in adults with severe mitral regurgitation who are high-risk for open-heart surgery.

  Recruiting at 2 sites InnovHeart · Los Angeles, California and 4 other locations · NCT07130994

• Outcomes after new edge-to-edge mitral valve repair

  This project will follow people with mitral regurgitation who receive transcatheter edge-to-edge repair at Amsterdam UMC to see how they do long-term and whether patient selection can be improved.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam, North Holland · NCT07108907

• Surgical implantation of a polymer prosthetic mitral or aortic valve

  This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.

  Recruiting Mitrassist Lifesciences Limited Co., Ltd. · Shanghai, Shanghai Municipality · NCT07097740

• GeminiOne transcatheter edge-to-edge repair for severe symptomatic mitral regurgitation

  This trial will try the GeminiOne TEER system to treat adults with severe, symptomatic mitral regurgitation who are high surgical risk or have not improved with medical therapy.

  Recruiting Sierra Valve LLC · Thousand Oaks, California · NCT07086534

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.