Идёт набор NCT07293923

Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock

Без фазы С лечением Cardiogenic Shock Heart Failure Acute Myocardial Infarction (AMI)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Elevate™ System.
Кому может быть актуально: Состояния в реестре: Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI). Базовые параметры: 40 лет — 89 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Грузия, Израиль
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Clinical Feasibility Study of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients With Cardiogenic Shock

Обзор

The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left ventricular failure.

Подробное описание

The Elevate™ CS Clinical Feasibility Study is planned as a prospective, single-arm, interventional study.

Вмешательства

Устройство Elevate™ System
The Elevate™ percutaneous Left Ventricular Assist Device System

Первичные конечные точки

Initial Safety [Срок оценки: From device delivery through device removal]
Device Effectiveness [Срок оценки: From baseline to 30 minutes of device activation]
Device Performance [Срок оценки: From device delivery through device removal]

Критерии участия

Критерии включения

Cardiogenic shock of less than 24 hours duration.
Left ventricular ejection fraction < 45% and > 15%, as determined by echocardiography on the day of inclusion.
No more than mild right ventricular dysfunction, as determined by echocardiography on the day of inclusion.
Signed informed consent.

Критерии исключения

Other causes of shock: hypovolemia, sepsis (any active systemic infection including acute myocarditis), pulmonary embolism or anaphylaxis.
Patient with oxygen saturation < 90% (pulse oximeter/arterial) at the planned time of device placement (uncorrected by oxygen supplementation or intubation).
Sustained VT (at the time of the enrollment).
Significant right heart failure/right ventricular dysfunction.
Awake patient who is unable to remain in a stable recumbent position due to restlessness or lack of cooperation for other reasons.
Hypertrophic obstructive cardiomyopathy.
Left ventricular thrombus.
Subjects with a placed IABP.
Mitral and/or aortic valve prothesis, or more than mild native mitral or aortic valve stenosis.
Aortic valve insufficiency ≥ 2+ (on a 4-grade scale).
Mechanical complication of myocardial infarction (e.g., ventricular septal rupture, papillary muscle rupture) or evidence of uncorrected Ventricular Septal Defect or Atrial Septal Defect (VSD/ASD).
Brain damage (e.g., anoxic) or suspected brain damage.
Stroke or transient ischemic attack within the past 3 months.
Uncorrectable abnormal coagulation parameters (defined as platelet count < 100,000 or INR > 2.0 or fibrinogen < 1.5 g/L) or active uncontrolled bleeding.
Allergy, sensitivity or intolerance to heparin, aspirin, Adenosine Diphosphate (ADP) receptor blockers, or contrast media, including known heparin-induced thrombocytopenia.
Known allergy, sensitivity or intolerance to nickel.
Known or suspected severe lung disease.
Evidence of any vascular disease that would preclude placement of the device (e.g., severely calcified and stenosed ilio-femoral vessels).
Aortic pathology, such as aortic aneurysms, extreme tortuosity, or calcifications that could pose an undue additional risk to the placement of a pLVAD device.
Any known or suspected disorder causing fragility of blood cells or hemolysis.
Subject participation in another investigational drug or device trial (post-market registries may be approved by Magenta Medical).
Life expectancy < 1 year due to comorbidities.