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

Официальное название

ContraBand™ Safety & Feasibility Study for Treatment of Heart Failure

Обзор

ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries. The effect is achieved by causing a local reduction in the internal diameters of the branch PAs, resulting in a lower distal systolic pulmonary artery pressure (PAP) as well as an attenuation in the rise of the mean pulmonary capillary wedge pressure (PCWP) along with a higher pulmonary arterial compliance (PAC) distal to the constriction during exercise. Lower PCWP reflects the reduced left ventricular end diastolic pressure (LVEDP), contributing to enhanced ventricular filling and improved cardiac output. This hemodynamic change is anticipated to translate into enhanced physical capacity and a potentially more favorable prognosis for heart failure subjects. This study is an early feasibility, multi center, prospective, interventional, open-label, single-arm study.

Вмешательства

• Устройство ContraBand implants
  Percutaneous implantation of the ContraBand devices by right heart catheterization

Первичные конечные точки

• Device-related or procedure-related major adverse events (MAEs) [Срок оценки: 30 days]

Вторичные конечные точки (1)

• Procedural success [Срок оценки: Implantation procedure]

Критерии участия

Main Inclusion Criteria:

• Age is 18 - 85 years old
• Chronic heart failure (> 3 months)
• Symptomatic left heart failure Stage C (NYHA Class III-IVa) or Class II with documented prior history of Class III-IVa heart failure.
• LVEF 20 - 40%
• 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%).
• 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.
• Able to complete six-minute walk test (6MWT) with distance between 100 meters and 400 meters.

Main Exclusion Criteria:

• Serum NT-proBNP <300 pg/mL
• Significant RV dysfunction with TAPSE < 15 mm
• Moderate to severe pulmonary hypertension (Pulmonary vascular resistance PVR ≥ 4.0 WU and PAPi < 1.0 by RHC)
• Anatomical pathology or constraints preventing appropriate access/implant of ContraBand™
• Restrictive Cardiomyopathy or myocarditis
• 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)
• Leukopenia (WBC < 4000 cells/μL), anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 150,000 cells/μL) or any known blood clotting disorder
• 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
• Previous history of cardiogenic shock (unrelated to myocardial infraction)
• Stroke, transient ischemic attack (TIA) or deep vein thrombosis (DVT) within 6 months of screening

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 3 центра

• Clinical Site — Aalst
• Clinical Site — Antwerp
• Clinical Site — Genk

Израиль · 3 центра

• Clinical Site — Nahariya
• Clinical Site — Petah Tikva
• Kaplan Medical Center — Rehovot

Литва · 2 центра

• Clinical Site — Klaipėda
• Vilnius University Hospital Santaros Klinikos — Vilnius

Польша · 2 центра

• Clinical Site — Krakow
• Clinical Site — Lublin

Грузия · 1 центр

• Tbilisi Heart and Vascular Clinic — Tbilisi

Германия · 1 центр

• Clinical Site — Lübeck

Идентификаторы

NCT: NCT05230745 · RM-20-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗