Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

Functional Tricuspid Regurgitation Clinical Trial

Official title:

Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836415
• Other study ID #: EDTA3D
• Status: Completed
• Start date: December 2, 2020
• Est. completion date: December 29, 2020

Study information

• Verified date: April 2023
• Source: Ospedale San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: December 29, 2020
• Est. primary completion date: December 29, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients
• Operated for functional TR
• Implantation of three-dimensional tricuspid prosthetic ring MC3 or Contour 3D, isolated or concomitant to surgery on the left heart sections
• Surgical access in median sternotomy or minithoracotomy

Exclusion Criteria:

• emergency/urgency intervention

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid valve annuloplasty with 3D ring
A 3D ring is implanted to treat functional tricuspid valve regurgitation

Locations

Country	Name	City	State
Italy	IRCCS Ospedale San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Michele De Bonis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		through study completion, an average of 7 years