Niewydolność serca: badanie kliniczne

Kryteria włączenia kto może wziąć udział (25)

1. Main Inclusion Criteria:
2. Age is 18 - 85 years old
3. Chronic heart failure (> 3 months)
4. Symptomatic left heart failure Stage C (NYHA Class III-IVa) or Class II with documented prior history of Class III-IVa heart failure.
5. LVEF 20 - 40%
6. 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%).
7. 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.
8. Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters. Main Exclusion Criteria:
9. Serum NT-proBNP <300 pg/mL
10. Significant RV dysfunction with TAPSE < 15 mm
11. Moderate to severe pulmonary hypertension (Pulmonary vascular resistance PVR ≥ 4.0 WU and PAPi < 1.0 by RHC)
12. Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
13. Restrictive Cardiomyopathy or myocarditis
14. Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5)
15. Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
16. Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis)
17. Any planned cardiac surgery or interventions within the next six (6) months
18. Need for coronary artery revascularization
19. Myocardial infarction or any percutaneous cardiovascular intervention within 1 month
20. Cardiovascular surgery, or carotid surgery within 3 months
21. Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR < 30)
22. Leukopenia (WBC < 4000 cells/μL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/μL) or any known blood clotting disorder
23. 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
24. Previous history of cardiogenic shock (unrelated to myocardial infraction)
25. Stroke, transient ischemic attack (TIA) or deep vein thrombosis (DVT) within 6 months of screening