Tricuspid Valve InsufficiencyNCT03604484
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
A study testing Tricuspid annuloplasty in people with Tricuspid Valve Insufficiency, run by Université Catholique de Louvain.
Trial summary
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tricuspid Valve Insufficiency
- What is being tested?
- Tricuspid annuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2009to 1 Jan 2017
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Who cannot join
- presence of pacemaker lead through the tricuspid valve
- acute endocarditis
- minimally invasive approach
- Functional mitral valve insufficiency
About this study
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
Read the detailed description
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.
- Conditions
- Tricuspid Valve Insufficiency
- Being tested
- Tricuspid annuloplasty
- 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.
Tricuspid annuloplastyProcedure or surgery
Tricuspid annuloplasty
| Study group | Role | What they receive |
|---|---|---|
| Tricuspid annuloplasty | Active comparator | Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery Receives: Procedure: Tricuspid annuloplasty |
| No Tricuspid annuloplasty | No intervention | Control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of more than mild tricuspid insufficiency
Measured: 5 year
Secondary outcomes (2)
VO2 max
Physical function capacity measured by VO2 max
Measured: 1 year
Right ventricular function
Right ventricle function at the follow up
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 May 2009
- Primary completion31 Dec 2010
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pettinari Matteo, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604484
- Sponsor's protocol ID
- UCLSaint Luc
- Status last verified
- Jul 2018
- First submitted
- 11 Jul 2018
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
- ClinicalTrials.gov ID
- NCT03604484
- Acronym / sponsor ID
- UCLSaint Luc
- Conditions
- Tricuspid Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 May 2009 (actual)
- Primary completion
- 31 Dec 2010 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 27 Jul 2018 (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.
Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
Detailed description
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tricuspid annuloplasty | Active comparator | Procedure: Tricuspid annuloplastyPatient treated with tricuspid annuloplasty at the moment of the mitral valve surgery |
| No Tricuspid annuloplasty | No intervention | –Control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Key exclusion criteria (4 listed)
- presence of pacemaker lead through the tricuspid valve
- acute endocarditis
- minimally invasive approach
- Functional mitral valve insufficiency
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 annuloplastyTricuspid annuloplasty | Procedure or surgery | Tricuspid annuloplasty |
Primary outcome
Incidence of more than mild tricuspid insufficiency
Time frame: 5 year
2 secondary outcomes
VO2 max
Time frame: 1 year
Right ventricular function
Time frame: 5 year
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 27 Jul 2018.
Related trials for Tricuspid Valve Insufficiency
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The TRICURE EFS Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
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TRISCEND JAPAN Study
Tricuspid Valve Regurgitation, Heart Valve Diseases
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
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The TRICURE US IDE Pivotal Study
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EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
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.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid annuloplasty in people with Tricuspid Valve Insufficiency, run by Université Catholique de Louvain.
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 1 inclusion and 4 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 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of more than mild tricuspid insufficiency (time frame: 5 year). 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 27 Jul 2018.