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

A regiszterben nem jelölt feltételek

• Main Inclusion Criteria:
• Age is 18 - 85 years old
• Chronic heart failure (> 3 months)
• Symptomatic left heart failure Stage C (NYHA Class III-IVa) or Class II with documented prior history of Class III-IVa heart failure.
• LVEF 20 - 40%
• Receiving optimally tolerated GDMT for at least 3 (three) months as referred in the 2021 ESC Guidelines for the optimal recommended pharmacological treatment indicated in patients with (NYHA class II-IV) heart failure with reduced ejection fraction (LVEF< 40%).
• If indicated according to the 2021 ESC Guidelines: Subject has an implantable cardioverter-defibrillator (ICD) for at least 1 month prior to screening. or subject is on cardiac resynchronization therapy (CRT)/pacemaker for at least 3 months prior to screening.
• Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters.
  • Main 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