Heart Failure, Left Sided Clinical Trial
Official title:
ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure
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.
Status | Recruiting |
Enrollment | 55 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
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) 18. Leukopenia (WBC < 4000 cells/µL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/µL) or any known blood clotting disorder |
Country | Name | City | State |
---|---|---|---|
Belgium | ZNA Middelheim | Antwerpen | |
Georgia | Tbilisi Heart and Vascular Clinic | Tbilisi | |
Israel | Kaplan Medical Center | Re?ovot | |
Lithuania | Vilnius University Hospital Santaros Klinikos | Vilnius | |
Poland | Clinical Site | Lublin |
Lead Sponsor | Collaborator |
---|---|
Restore Medical Ltd |
Belgium, Georgia, Israel, Lithuania, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Device-related or procedure-related major adverse events (MAEs) | MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; embolization and heart failure- related hospitalization. | 30 days | |
Secondary | Procedural success | Ability to successfully deliver devices to the Pulmonary Arteries | Implantation procedure |
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