A Feasibility Study of the CroíValve DUO System for Tricuspid Regurgitation

Inclusion criteria

• Presence of severe Tricuspid Regurgitation per American Society of Echocardiography (ASE) Criteria determined by Echo Core Lab assessment of a qualifying Transthoracic Echocardiogram (TTE).
• Subject is symptomatic despite medical therapy (NYHA Functional Class II or higher)
• Subject is on stable medical therapy as assessed by the Heart Team
• The patient's anatomy is suitable in the judgment of the Investigational Site Heart Team and the Patient Screening Committee.
• Age ≥18 years
• The patient or the legal representative has been informed of the nature of the study and agrees to its provisions and has provided written informed consent on a form, as approved by the EC of the respective clinical site.

Exclusion criteria

• Subject is currently participating in another clinical investigation that could affect the outcome of this trial
• Transesophageal echocardiography (TEE) is contraindicated or unsuccessful
• Previous tricuspid valve repair, replacement or transcatheter tricuspid intervention
• Moderate to severe tricuspid valve stenosis
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• Significant comorbid factors which places the subject at prohibitive risk for surgical repair in the judgment of the Investigational Site Heart Team and the Patient Screening Committee
• Need for concomitant surgical or interventional procedure known at time of screening (e.g., CABG, Atrial Septal Defect (ASD) repair).
• Ejection Fraction (EF) <30% within 45 days of the implant procedure
• Echocardiographic or CT evidence of 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: Severe COPD or continuous use of home oxygen or has FEV1 <50% of predicted
• Severe right ventricular dysfunction as determined by the Echo Core Lab
• Untreated clinically significant coronary artery disease requiring revascularization surgical or interventional PCI
• Stroke or transient ischemic event within 90 days prior to the implant procedure
• Untreated severe symptomatic carotid stenosis (>70% by ultrasound)
• Acute myocardial infarction within 30 days before the index procedure
• Renal insufficiency (eGFR<25 ml/min)
• Active endocarditis within 6 months of the implant procedure
• Pulmonary embolism within the last 6 months
• Any surgical, interventional, or transcatheter procedure within 30 days prior to the index procedure
• Patient has an SVC dimension/anatomy is not suitable for device implantation (i.e., extremely tortuous, heavily calcified, aneurysmal)
• Hypertrophic cardiomyopathy, restrictive cardiomyopathy or constrictive pericarditis
• Life expectancy <1 year
• Active infections requiring current antibiotic therapy
• Known severe liver disease
• Prior heart or lung transplant
• Known active peptic ulcer or active GI bleed
• Unable to take anticoagulant therapy
• Known patient is actively abusing drugs
• Subjects who are pregnant or planning to become pregnant
• Any condition making it unlikely the subject will be able to complete all protocol procedures (including compliance with guideline-directed medical therapy and immobility that would prevent completion of 6MWT), follow-up visits, or impact the scientific soundness of the clinical investigation result
• Any known major coagulation abnormalities, thrombocytopenia, platelets <50,0000/ml or anemia Hb <9g/dl
• Any known sensitivities or allergies to contrast and/or the device materials, including nickel and titanium
• BMI >50kg/m2
• Transvalvular implanted pacemaker or ICD lead is present