Tricuspid RegurgitationNCT05836493
Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
An observational study of Tricuspid Regurgitation, run by Michele De Bonis at 1 site in Italy.
Trial summary
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome 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
- Tricuspid Regurgitation
- What is being tested?
- Ring annuloplasty and Suture procedure
- Type of treatment
- Surgery or procedure
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 7 Oct 2020to 23 Oct 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
- No healthy volunteers
- Adult, Older adult
Study population: - patients operated for non-valvular procedures (e.g. coronary artery bypass)
Who may be able to join
- cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart
- patients operated on between January 1998 and December 2004
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Interest in Tricuspid valve disease grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).
- Conditions
- Tricuspid Regurgitation
- Being tested
- Ring annuloplasty, Suture procedure
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ring annuloplastyProcedure or surgery
A prosthetic ring is implanted to treat tricuspid regurgitation
Suture procedureProcedure or surgery
Suture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation
| Study group | Role | What they receive |
|---|---|---|
| Ring annuloplasty | Not described Receives: Procedure: Ring annuloplasty | |
| Suture procedure | Not described Receives: Procedure: Suture procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: through study completion, a minimum of 15 years
Secondary outcomes (2)
Reintervention
Measured: through study completion, a minimum of 15 years
TR recurrence
Measured: through study completion, a minimum of 15 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 start7 Oct 2020
- Primary completion23 Oct 2020
- Study completion23 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 146 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
- NCT05836493
- Sponsor's protocol ID
- VLT-TVR
- 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
- Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
- ClinicalTrials.gov ID
- NCT05836493
- Acronym / sponsor ID
- VLT-TVR
- Conditions
- Tricuspid Regurgitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 23 Oct 2020 (actual)
- Study completion
- 23 Oct 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 grew exponentially in the last years in response to an increased awareness of the poor outcome of patients with functional Tricuspid Regurgitation (TR). Earlier reports advocated for a more conservative TR management in patients undergoing left-sided heart valve surgery but more recent guidelines advised for a more aggressive TR management, as accumulating evidence demonstrates its adverse impact on long term morbidity and mortality. Several papers have been published analyzing the results of surgical tricuspid valve repair but the length of the follow-up is usually limited to 10 to 12 years. With this study the investigators aim to analyze the very long-term results (>15years) of tricuspid valve repair according to the surgical method employed for valve repair (suture vs ring annuloplasty).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ring annuloplasty | – | Procedure: Ring annuloplasty |
| Suture procedure | – | Procedure: Suture procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- - patients operated for non-valvular procedures (e.g. coronary artery bypass)
Key inclusion criteria (2 listed)
- cardiac surgery treatment of TR, isolated or in conjunction with other procedures on the left heart
- patients operated on between January 1998 and December 2004
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ring annuloplastyA prosthetic ring is implanted to treat tricuspid regurgitation | Procedure or surgery | Ring annuloplasty |
| Suture procedureSuture techniques such as Kay or De Vega are used to reduce tricuspid annulus in order to treat tricuspid regurgitation | Procedure or surgery | Suture procedure |
Primary outcome
Mortality
Time frame: through study completion, a minimum of 15 years
2 secondary outcomes
Reintervention
Time frame: through study completion, a minimum of 15 years
TR recurrence
Time frame: through study completion, a minimum of 15 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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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 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 2 inclusion and 0 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, a minimum of 15 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.