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.
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.
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.
- Conditions
- Functional Tricuspid Regurgitation
- 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.
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.
- First posted1 May 2023
- Study start2 Dec 2020
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Tricuspid RegurgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Michele De Bonis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele De Bonis, Ospedale San Raffaele
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