Overview

The ContraBand™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy. ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries, causing a local reduction in the internal diameters of these arteries, and resulting in an elevation in systolic right ventricular pressure. This may result in repositioning the interventricular septum to a more normal anatomical position, and supporting it with a "counter-pressure" during systole of the left ventricle. This study is a first-in-human, early feasibility, multi center, prospective, interventional, open-label, single-arm study.

Eligibility

Inclusion Criteria:

1. Age is 18 - 85 years old
2. Chronic (> 3 months) systolic heart failure
3. Symptomatic left heart failure Stage C (NYHA II*-IVa)
4. LVEF 20 - 40%
5. Patients on optimal tolerated medical therapy for at least one month. If subject is on device therapy, if ICD for at least 1 month, if CRT/pacemaker, for at least 3 months.
6. Provide a personally signed and dated inform consent form, and able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule.

Exclusion Criteria (selected):

1. Serum NT-proBNP <300
2. Significant RV dysfunction with TAPSE <17
3. Pulmonary Hypertension (sPAP > 45 mmHg by Echo or mPAP > 20 mmHg by RHC)
4. Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
5. Restrictive Cardiomyopathy or myocarditis
6. Patients with congenital heart disease and/or mechanical heart valve(s)
7. Any severe valve disease (Grade 3-4) and/or tricuspid regurgitation ≥ 2+ (in a scale of 5)
8. Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
9. Active bacterial endocarditis or previous history of SBE (Subacute bacterial endocarditis)
10. Any planned cardiac surgery or interventions within the next six (6) months
11. Need for coronary artery revascularization
12. Myocardial infarction or any percutaneous cardiovascular intervention within 1 month
13. Cardiovascular surgery, or carotid surgery within 3 months
14. Acute kidney insufficiency and/or end stage renal disease requiring chronic dialysis (eGFR < 30)
15. Leukopenia (WBC < 4000 cells/μL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/μL) or any known blood clotting disorder