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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05230745
Other study ID # RM-20-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date December 31, 2026

Study information

Verified date November 2023
Source Restore Medical Ltd
Contact Stephen Bellomo
Phone +972 54 227 4831
Email stephen@restoremedical.co
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ContraBand implants
Percutaneous implantation of the ContraBand devices by right heart catheterization

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Restore Medical Ltd

Countries where clinical trial is conducted

Belgium,  Georgia,  Israel,  Lithuania,  Poland, 

Outcome

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
See also
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Terminated NCT03148847 - Management of Cardiogenic Pulmonary Edema (RENAU-OAP)
Completed NCT04397302 - Role of Sacubitril/Valsartan in the Improvement of Heart Failure With Reduced Ejection Fraction