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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Durability Long-term Results of Tricuspid Annuloplasty With 3D Shaped Rings.
- ClinicalTrials.gov ID
- NCT05836415
- Acronym / sponsor ID
- EDTA3D
- Conditions
- Functional Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent tricuspid surgery due to functional tricuspid regurgitation, treated with implant of a 3D ring
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- emergency/urgency intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricuspid valve annuloplasty with 3D ringA 3D ring is implanted to treat functional tricuspid valve regurgitation | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: through study completion, an average of 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Comparing the Effects of Newer Pacemakers and Their Effects on the Heart and Valve Function in the Short-term.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Tricuspid Regurgitation, run by Michele De Bonis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: through study completion, an average of 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.