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Functional Tricuspid RegurgitationNCT05836415

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

An observational study of Functional Tricuspid Regurgitation, run by Michele De Bonis at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Functional Tricuspid Regurgitation
What is being tested?
Tricuspid valve annuloplasty with 3D ring
Type of treatment
Surgery or procedure
How many people
168 participants
Where
1 siteItaly
Study dates
2 Dec 2020to 29 Dec 2020
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients who underwent tricuspid surgery due to functional tricuspid regurgitation, treated with implant of a 3D ring

Who may be able to join

  • 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

Who cannot join

  • emergency/urgency intervention

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • IRCCS Ospedale San Raffaele

    Milan, 20132

Other trials in Italy

About this study

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.

Being tested
Tricuspid valve annuloplasty with 3D ring

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tricuspid valve annuloplasty with 3D ringProcedure or surgery

    A 3D ring is implanted to treat functional tricuspid valve regurgitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality

    Measured: through study completion, an average of 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2023
  2. Study start2 Dec 2020
  3. Primary completion29 Dec 2020
  4. Study completion29 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05836415
Sponsor's protocol ID
EDTA3D
Status last verified
Apr 2023
First submitted
27 Jan 2023
Last updated
1 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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