Laplace Early Feasibility Study - Canada

Exclusion Criteria

• •1. Estimated life expectancy of less than 12 months
• •2. Systolic pulmonary artery pressure \> 65mmHg per TTE.
• •3. PVR \>5 Wood units
• •4. Acutely decompensated defined as hypotension with SBP \<90 mmHg, use of hemodynamic support devices or inotropes within the last 30 days
• •5. Severe COPD dependent on home oxygen or chronic home oxygen use
• •6. Echocardiographic evidence of severe right ventricular dysfunction
• •7. Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
• •8. New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation
• •9. Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• •10. Untreatable hypersensitivity or contraindication to any of the following: Aspirin, and Clopidogrel or Ticlopidine, Heparin, and Bivalirudin, Warfarin, or DOAC, Nitinol Alloys. Severe renal insufficiency defined as eGFR \<25 mL/min or requiring chronic renal replacement therapy at the time of screening committee review.
• •12\. Current history (within last 5 years) of illicit drug use. 13. Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery, within last 30 days. Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator or leadless pacemaker within 90 days prior to the study procedure 14. Need for emergent, urgent or planned surgery or intervention within 30 days following the study procedure. Planned or scheduled cardiac surgery within next 12 months. 15. Stroke or other major cerebrovascular event within 90-days prior to index procedure 16. Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction. 17. Active or recent GI bleed within 30 days prior to study procedure or patients Contraindicated for oral anticoagulation therapy 18. Bleeding disorders including thrombocytopenia or platelet count \<70,000 mm 3 or thrombocytosis (platelet count \>700,000 /mm 3
• •Transfusion dependent chronic anemia with Hb \<9/dL
• •Current or planned pregnancy within next 12 months for women of childbearing potential
• •Active or recent endocarditis within last 90 days or, sepsis/ other systemic infection requiring oral or intravenous antibiotics within last 30 days
• •Prior tricuspid repair or tricuspid replacement or other device that would interfere with successful deployment or functioning of Laplace tricuspid valve.
• •Participation in another pre-market investigational device study or investigational drug study for a cardiac related drug
• •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. Any patient considered to be vulnerable.
• •Left ventricular ejection fraction (LVEF) \< 30%
• •Deep vein thrombosis or pulmonary embolism within last 6 months
• •Child-Pugh C cirrhosis.
• •Contraindication or inability to complete TEE