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

Study Overview
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Brief Summary
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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.

Official Title
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ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Conditions
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Heart Failure, Left Sided

Intervention / Treatment
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* Device: ContraBand implants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is 18 - 85 years old Chronic (> 3 months) systolic heart failure Symptomatic left heart failure Stage C (NYHA II*-IVa) LVEF 20 - 40% 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. 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): Serum NT-proBNP <300 Significant RV dysfunction with TAPSE <17 Pulmonary Hypertension (sPAP > 45 mmHg by Echo or mPAP > 20 mmHg by RHC) Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™ Restrictive Cardiomyopathy or myocarditis Patients with congenital heart disease and/or mechanical heart valve(s) 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) 18. Leukopenia (WBC < 4000 cells/μL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/μL) or any known blood clotting disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ContraBand implants<br>Percutaneous implantation of the ContraBand devices by right heart catheterization | Device: ContraBand implants<br>* Percutaneous implantation of the ContraBand devices by right heart catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success | Ability to successfully deliver devices to the Pulmonary Arteries | Implantation procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary artery banding