Status
Conditions
Treatments
Study type
Funder types
Identifiers
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Pre-Inclusion Criteria:
Age ≥ 18 years
Symptomatic secondary (at least) severe TR (Carpentier Type IIIB (restrictive) and / or I (tricuspid annulus dilation)) stable for at least 30 days
NYHA functional class II to IV without cirrhosis and/or ascites
Signs of heart failure in the previous 12-months with or without having been hospitalized
Stable optimized medical and/or interventional treatment
Ineligible for corrective action on the valve by surgical approach after a specialized multidisciplinary consultation ("heart team") including at least a cardio-thoracic surgeon, an interventional cardiologist, an imaging-cardiologist and an Anesthesiologist).
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:
Patient treated with Mitraclip or other percutaneous approach on the mitral valve in the past 3-month
Any prior tricuspid valve procedure that would interfere with placement of the Triclip device
Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:
Myocardial infarction or coronary bypass surgery in the past 3-month
Left ventricular ejection fraction ≤35%
Cardiac Resynchronization therapy for less than 3-month and patients having a TR that is clearly related to the right ventricular lead positioning
Cardioversion for less than 6 weeks
Life expectancy irrespective of the valvular heart disease <1 year (due to co-morbidities)
Other scheduled cardiac surgery (including registration in cardiac transplant list)
Coronary angioplasty in the preceding month
Current infection requiring prescription of antibiotics
End-stage renal failure (dialysis patient)
Severe hepatic insufficiency (disruption of liver metabolism associated with coagulation disorders (factor V <50%))
Stroke in the previous 3-month
Uncontrolled pre- capillary pulmonary hypertension (right catheterization required) (systolic pulmonary pressure > 60 mmHg)
Tricuspid prosthetic valve
Pace maker lead or ICD lead that would prevent appropriate placement of the Triclips
Nitinol allergy
Contraindication, allergy or hypersensibility to dual anti-platelet and anticoagulant therapy
Ongoing infection requiring antibiotic therapy
Evidence of intra vascular or intra cardiac thrombus
Patient who are included in another research protocol
Protected person (adults legally protected (under judicial protection, guardianship or supervision), person deprived of their liberty, pregnant woman, lactating woman and minor)
Absence of coverage by a social security scheme
Primary purpose
Allocation
Interventional model
Masking
300 participants in 2 patient groups
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal