Evaluation of Tricuspid Valve Percutaneous Repair System in the Treatment of Severe Secondary Tricuspid Disorders

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.

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:

• Regurgitation volume > 45 mL / beat
• Surface of the regurgitant orifice > 40 mm²
• Vena contracta> 7mm
• Gap between leaflets ≤ 10 mm (at the presumed location of the clip)

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:

• Tricuspid valve anatomy not evaluable by TTE and TEE
• Active endocarditis
• Evidence of calcification in the grasping area
• Evidence of stenosis (mean pressure gradient > 5 mmHg or surface area ≤1cm²
• Presence of a severe coaptation defect (> 1cm) of the tricuspid leaflets
• Severe leaflet defect(s) preventing proper device placement
• Epstein anomaly - identified by having a normal annulus position while the valve leaflets are attached to the walls and septum of the right ventricle
• 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