EFS of the DUO System for Tricuspid Regurgitation

Multi-center, prospective, non-randomized, investigational, and pre-market. Data collected in this clinical study will include safety and function of the investigational system as well as up to 5 year clinical outcomes.

Inclusion criteria

• Presence of severe or greater tricuspid regurgitation as determined by the Echo Core Lab.
• Patient is symptomatic despite medical therapy.
• The local Site Heart Team determines the Patient is appropriate for transcatheter valve intervention.
• The Patient's anatomy is suitable in the judgment of the Patient Selection Committee.
• Age ≥18 years
• The Patient has been informed of the nature of the study and agrees to its provisions and has provided written Informed Consent.

Exclusion criteria

• Patient is currently participating in another clinical investigation that could affect the outcome of this trial.
• Any previous tricuspid valve intervention that would interfere with the placement of the investigational device.
• Moderate or greater tricuspid valve stenosis.
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of the investigational device.
• Need for concomitant surgical or interventional procedure, known at the time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• Ejection Fraction (EF) <25%
• Echocardiographic evidence of unstable intracardiac mass, thrombus or vegetation
• Patient has Systolic Pulmonary Pressure (sPAP) >60 mm Hg
• Severe hemodynamic instability: cardiogenic shock or the need for inotropic support or Intra-Aortic Balloon Pump (IABP) or other percutaneous ventricular assist devices
• Severe respiratory instability with continuous use of home oxygen
• Severe right ventricular dysfunction
• Untreated clinically significant coronary or carotid artery disease requiring revascularization surgical or interventional PCI.
• Stroke or transient ischemic event within 90 days prior to the index procedure
• Acute myocardial infarction within 30 days before the index procedure
• Renal insufficiency (eGFR <25 ml/min) or currently on chronic dialysis
• Active endocarditis within 6 months of the index procedure
• Pulmonary embolism or deep vein thrombosis within the last 6 months
• Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• Life expectancy <1 year
• Active infections requiring current antibiotic therapy
• Known severe liver disease
• Is on the waiting list for a transplant or has had a prior heart or lung transplant
• Known active peptic ulcer or active GI bleed
• Unable to take anticoagulant therapy
• Any known major coagulation abnormalities, thrombocytopenia, platelets < 50,000/ml or severe anemia Hb <8 g/dl
• Known patient is actively abusing drugs
• Any known sensitivities or allergies to contrast (that cannot be adequately premedicated) and/or the device materials, including nickel and titanium
• Patients who are pregnant or intend to become pregnant
• Any condition making it unlikely the Patient will be able to complete all protocol procedures (including compliance with optimal medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result