Evaluation of Tricuspid Valve Percutaneous Repair System in the Treatment of Severe Secondary Tricuspid Disorders (TRI-FR)
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|ClinicalTrials.gov Identifier: NCT04646811|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2020
Last Update Posted : February 2, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Tricuspid Regurgitation||Procedure: Tricuspid valve Other: Best medical treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TRI-FR : Multicentric Randomized Evaluation of Tricuspid Valve Percutaneous Repair System (Clip for the Tricuspid Valve) in the Treatment of Severe Secondary Tricuspid Disorders|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||July 2027|
Experimental: Tricuspid valve
tricuspid valve percutaneous repair strategy with clip for the tricuspid valve
Procedure: Tricuspid valve
Clip for the tricuspid valve implantation on top of best medical therapy
|Best medical treatment||
Other: Best medical treatment
Best medical therapy alone
- Milton Packer clinical composite score [ Time Frame: 12 months ]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
- 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 [ Time Frame: 0 and 12 months ]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.
- quality of life score [ Time Frame: 6 and 12 months ]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.
- quality of life score [ Time Frame: 6 and 12 months ]Minnesota Living with Heart Failure (MLHF)
- quality of life score [ Time Frame: 6 and 12 months ]
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'.
- quality of life score [ Time Frame: 6 and 12 months ]Patient global assessment (PGA)
- functional evaluation [ Time Frame: 6 and 12 months ]NYHA functional class
- severity of the Tricuspid Regurgitation (TR) [ Time Frame: 6 and 12 months ]TR grade
- walking distance [ Time Frame: 6 and 12 months ]6-minute walk test
- echocardiography parameters [ Time Frame: 6 and 12 months ]right heart function
- echocardiography parameters [ Time Frame: 6 and 12 months ]right heart cavities sizes
- echocardiography parameters [ Time Frame: 6 and 12 months ]degree of tricuspid regurgitation
- echocardiography parameters [ Time Frame: 6 and 12 months ]stenosis
- biological parameters [ Time Frame: 6 and 12 months ]parameters renal : creatinine, clearance, AST
- biological parameters [ Time Frame: 6 and 12 months ]hepatic function
- biological parameters [ Time Frame: 6 and 12 months ]NT-proBNP
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04646811
|Contact: Mevel Nicolas||02 99 28 25 email@example.com|
|Contact: Ganivet Anne||02 99 28 25 firstname.lastname@example.org|
|Principal Investigator:||Donal Erwan||CHU Rennes|