IRCCS Ospedale San Raffaele
Milan, 20132, Italy
NCT Number: NCT05836415
Interest in tricuspid valve disease has grown exponentially over the past few years, in response to increased interest in the poor prognosis of patients with functional tricuspid regurgitation (TR). Tricuspid valve repair (TVR) using a prosthetic ring represents the first option in many centers worldwide, due to the low incidence of residual and recurrent TR and improved survival compared to suture techniques. The goal of ring annuloplasty is to restore the normal geometry of the annulus, thereby improving the coaptation of the leaflets and preventing further dilatation of the annulus. Recently, the three-dimensional geometry of the tricuspid valve has been shown and analyzed by means of data obtained from echocardiography, CT scan and magnetic resonance imaging. Normal tricuspid annulus is characterized by a more prominent part in the anteroseptal commissure area near the aortic valve and right ventricular outflow tract and a deeper part in the posteroseptal commissure area near the coronary sinus ostium . Based on these characteristics, new three-dimensional rings have been developed for tricuspid annuloplasty, such as the MC3 (Edwards Lifescience, Irvine, CA) and the Contour 3D (Medtronic, Minneapolis, MN).
There are few studies concerning the short-term results of tricuspid rings implantation and almost none on the long-term, therefore this study aims to analyze the long-term results of TVR by implantation of the two new prosthetic ring models mentioned above.
The aim of this study is the long-term analysis of the results of tricuspid annuloplasty with three-dimensional rings in patients with functional IT.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Milan, 20132, Italy
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A 3D ring is implanted to treat functional tricuspid valve regurgitation
Time frame: through study completion, an average of 7 years
Michele De Bonis
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05648838
Functional Tricuspid Regurgitation
Daegu, Dalseo-gu, South Korea
View Trial DetailsNCT05854095
Functional Tricuspid Regurgitation
Daegu, Dalseo-gu, South Korea
View Trial DetailsNCT04078867
Functional Tricuspid Regurgitation
View Trial DetailsNCT05920824
Arrhythmias, Cardiac, Atrial Fibrillation
London, United Kingdom
View Trial Details