ContraBand™: Safety & Feasibility Study (RM-20-01)

Exclusion Criteria

• •Serum NT-proBNP \<300 pg/mL
• •Significant RV dysfunction with TAPSE \< 15 mm
• •Moderate to severe pulmonary hypertension (Pulmonary vascular resistance PVR ≥ 4.0 WU and PAPi \< 1.0 by RHC)
• •Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
• •Restrictive Cardiomyopathy or myocarditis
• •Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5)
• •Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
• •Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis)
• •Any planned cardiac surgery or interventions within the next six (6) months
• •Need for coronary artery revascularization
• •Myocardial infarction or any percutaneous cardiovascular intervention within 1 month
• •Cardiovascular surgery, or carotid surgery within 3 months
• •Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR \< 30)
• •Leukopenia (WBC \< 4000 cells/μL), anemia (Hgb \< 9 g/dL), thrombocytopenia (platelets \< 150,000 cells/μL) or any known blood clotting disorder
• •History of systemic or pulmonary thromboembolism within 12 months prior to Baseline visit; incidental small peripheral pulmonary emboli deemed clinically insignificant by the investigator are not considered exclusionary
• •Previous history of cardiogenic shock (unrelated to myocardial infraction)
• •Stroke, transient ischemic attack (TIA) or deep vein thrombosis (DVT) within 6 months of screening