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Search / Trial NCT06797687

Mitral Valve Annulus Assessment, Multimodality Imaging

Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jan 23, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the best ways to assess the size and shape of the mitral valve, which is important for successful heart surgery, specifically when repairing mitral valve regurgitation. Researchers want to compare two imaging techniques—three-dimensional echocardiography (3D-TOE) and cardiac computed tomography (CCT)—to see which provides more accurate measurements for choosing the right size of the prosthetic ring that doctors use during surgery. Accurate sizing is crucial because it can affect the outcome of the surgery and the patient's recovery.

To participate in this trial, you need to be at least 18 years old and have severe mitral valve regurgitation, requiring surgical treatment. You must also have had a pre-operative coronary CT scan to check for heart disease and be able to provide informed consent. During the trial, participants can expect to undergo imaging tests that help doctors measure their mitral valve accurately before surgery. This study is not yet recruiting, but it aims to improve how heart surgeries are performed, ultimately benefiting patients with similar heart conditions.

Gender

ALL

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

About Fondazione Policlinico Universitario Agostino Gemelli Irccs

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.

Locations

Roma, , Italy

Patients applied

0 patients applied

Trial Officials

Annalisa Pasquini, MD, PhD

Principal Investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported