Testing Laplace TTVR System for tricuspid regurgitation

Exclusion

• −Untreatable hypersensitivity or contraindication to any of the following: Aspirin, and Clopidogrel or Ticlopidine, Heparin, and Bivalirudin, Warfarin, or DOAC, Nitinol Alloys.
• −Estimated life expectancy of less than 12 months
• −Systolic pulmonary artery pressure \> 65mmHg per TTE.
• −PVR \>5 Wood units
• −Acutely decompensated defined as hypotension with SBP \<90 mmHg, use of hemodynamic support devices or inotropes within the last 30 days
• −Severe COPD dependent on home oxygen or chronic home oxygen use
• −Echocardiographic evidence of severe right ventricular dysfunction
• −Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation requiring treatment
• −New or untreated right heart chamber or/and superior vena cava intracardiac mass, thrombus, or vegetation
• −Presence of significant congenital heart disease including but not limited to hemodynamically significant atrial septal defect, RV dysplasia, and arrhythmogenic RV.
• −Severe renal insufficiency defined as eGFR \<25 mL/min or requiring chronic renal replacement therapy at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more → committee review.
• −Current history (within last 5 years) of illicit drug use.
• −Stroke or other major cerebrovascular event within 90-days prior to index procedure
• −Untreated clinically significant coronary artery disease requiring revascularization, recent (within last 30 days) acute coronary syndrome or myocardial infarction.
• −Active or recent GI bleed within 30 days prior to study procedure or patients Contraindicated for oral anticoagulation therapy
• −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
• −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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → 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
• −Current or planned pregnancy within next 12 months for women of childbearing potential
• −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
• −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.