An interventional study of Tricuspid valve and Best medical treatment in Tricuspid Regurgitation, sponsored by Rennes University Hospital. Completed at 26 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-17.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment
Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders.
This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk.
The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention.
A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery.
The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients.
For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality \~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.
The principal objective is to demonstrate, over a period of 12-month after randomization, that, on the Packer composite clinical endpoint (CCS) (combining NYHA class, patient global assessment (PGA) and major cardio-vascular events), the tricuspid valve percutaneous repair strategy with clip for the tricuspid valve is superior to best (optimized) medical treatment (BMT) in symptomatic patients with at least severe secondary TR. The Packer clinical composite score is eventually a three-level ordered categorical endpoint, each randomized patient being classifying as improved, unchanged, or worsen, depending on the clinical response over the follow-up period and at 12 months.
225 studies on the registry are indexed under Tricuspid Valve Insufficiency; 108 are open to participants now.
This study's enrollment of 300 is above the median of 60 across 124 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Pre-Inclusion Criteria:
Signature of an informed consent
Definitive Inclusion Criteria:
Central core-laboratory analysis : TR characterized before Implantation by at least one of the following criteria:
Then after the TR severity grading; the Clinical eligibility Committee will valid the inclusion.
Non Inclusion Criteria:
Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
tricuspid valve percutaneous repair strategy with clip for the tricuspid valve
Procedure: Tricuspid valve
Other: Best medical treatment
Clip for the tricuspid valve implantation on top of best medical therapy
Best medical therapy alone
Milton Packer clinical composite score
Milton Packer clinical composite score classifies each patient into 1 of 3 categories (improved, worsened, unchanged), and is determined aggregating evaluation functional using NYHA class, quality of life score using patient global assessment and number of major cardio-vascular events
Time frame: 12 months
number of participants with all-cause mortality
Time frame: 12 months
number of participants with tricuspid valve surgery
Time frame: 12 months
rate of heart failure hospitalizations
Time frame: 12 months
assessment of quality of life improvement
Kansas City Cardiomyopathy Questionnaire score (KCCQ) The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.
Time frame: 0 and 12 months
quality of life score
Kansas City Cardiomyopathy Questionnaire (KCCQ) The responses are categorized under 3 subscales (symptom burden, physical limitation and quality of life) with a range of possible subscale scores from 0 to 100, with 100 representing the least burden of symptoms. The total KCCQ score represents the mean of the three subscale scores.
Time frame: 6 and 12 months
quality of life score
Minnesota Living with Heart Failure (MLHF)
Time frame: 6 and 12 months
quality of life score
EQ5D-5L The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system : 5 dimensions : mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 levels : no problems,slight problems, moderate, problems and extreme. Each level corresponds to 1 digit number. The digits for the 5 dimensions are combined into a 5-digit number. The EQ VAS : on a vertical visual analogue scale, 100 'The best health you can imagine' 0 'The worst health you can imagine'.
Time frame: 6 and 12 months
quality of life score
Patient global assessment (PGA)
Time frame: 6 and 12 months
functional evaluation
NYHA functional class
Time frame: 6 and 12 months
severity of the Tricuspid Regurgitation (TR)
TR grade
Time frame: 6 and 12 months
walking distance
6-minute walk test
Time frame: 6 and 12 months
echocardiography parameters
right heart function
Time frame: 6 and 12 months
echocardiography parameters
right heart cavities sizes
Time frame: 6 and 12 months
echocardiography parameters
degree of tricuspid regurgitation
Time frame: 6 and 12 months
echocardiography parameters
stenosis
Time frame: 6 and 12 months
biological parameters
parameters renal : creatinine, clearance, AST
Time frame: 6 and 12 months
biological parameters
hepatic function
Time frame: 6 and 12 months
biological parameters
NT-proBNP
Time frame: 6 and 12 months
overall survival
Time frame: 6 and 12 months
number of cardiovascular death
Time frame: 6 and 12 months
number of major cardiovascular events
Time frame: 6 and 12 months
Incremental Cost-Effectiveness Ratio expressed as cost per QALY
Time frame: 12 and 24 months
Plan to share: No
Ran from Feb 2021 to primary completion in Apr 2024, 38 months.
Of 83 interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 58. This study's 38 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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