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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
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