Safety and Feasibility of the CorVad Percutaneous Ventricular Assist System in Refractory Right Heart Failure

Обзор

The goal of this clinical trial is to evaluate the safety and feasibility of the CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) in patients with right heart failure who continue to experience hemodynamic instability despite best medical therapy.

Вмешательства

• Устройство CorVad Percutaneous Ventricular Assist System
  The CorVad Percutaneous Ventricular Assist System (Device model: CorVad RS) is used to provide hemodynamic support by shareing some or all the workload of the right ventricles during the support period.

Первичные конечные точки

• The survival rate [Срок оценки: 30 days after device explant, or hospital discharge (whichever is longer), or to the induction of anesthesia to a longer-term therapy]

Вторичные конечные точки (10)

• Death [Срок оценки: 30 days after device explant, 90 days after device explant]
• Major Bleeding [Срок оценки: 30 days after device explant]
• Major hemolysis [Срок оценки: 30 days after device explant]
• Pulmonary embolism [Срок оценки: 30 days after device explant]
• Tricuspid and/or pulmonary valve dysfunction [Срок оценки: 30 days after device explant]
• MACCE [Срок оценки: 30 days after device explant, 90 days after device explant]
• Changes in CVP [Срок оценки: 24 hours after CorVad support]
• Changes in CI [Срок оценки: 24 hours after CorVad support]
• Changes in LVAD flow [Срок оценки: within 48 hours after CorVad support]
• Decreased use of inotropes/vasopressor during support [Срок оценки: during CorVad support, after 30 days post explant and after 90 days post explant]

Критерии участия

Критерии включения

• Patients who develop refractory right heart failure within 48 hours after left ventricular assist device (LVAD) implantation, myocardial infarction, heart transplantation, or open-heart surgery, defined as:

• despite ongoing treatment with oral heart failure medications, including continuous infusion of high-dose inotropic agents and/or vasopressors, and/or the use of more than one inotropic agent and/or vasopressor, the cardiac index (CI) remains less than 2.2 L/min/m²;
• and meets any one of the following criteria: 1) CVP > 15 mmHg; or, 2) CVP/pulmonary capillary wedge pressure (PCWP) or CVP/left atrial pressure (LAP) > 0.63; or, 3) echocardiographic evidence of moderate-to-severe right ventricular dysfunction meeting one of the following criteria: right ventricular basal diameter > 42 mm, right ventricular short-axis (or mid-chamber) diameter > 35 mm, tricuspid annular systolic excursion (TAPSE) score < 14 mm, right ventricular fractional area change (FAC) < 30%, tricuspid annular systolic peak velocity (TDI S') < 9 cm/s, and right ventricular free wall longitudinal strain > -20%.
• ≥ 18 years old.
• The patient or the patient's legal representative agrees to sign the informed consent form.

Критерии исключения

• INTERMACS Stage 1 is defined as: despite the use of inotropic agents (positive inotropic drugs) and/or temporary mechanical support (such as IABP or ECMO), the patient remains hypotensive and shows signs of inadequate perfusion of vital organs (such as oliguria or worsening liver function), requiring immediate initiation of mechanical circulatory support to survive.
• Severe hepatic or renal dysfunction, defined as total bilirubin ≥ 5 mg/dL or creatinine ≥ 4 mg/dL within 24 hours prior to treatment with the investigational device.
• For patients who have undergone LVAD implantation, acute neurological injury occurring after implantation, including stroke, hypoxic encephalopathy, or acute neurological deficits (such as seizures or altered levels of consciousness).
• Acute myocardial infarction with mechanical complications, including ventricular septal defect, cardiac rupture, or papillary muscle rupture.
• Failed revascularization (for patients requiring right coronary revascularization), defined as a TIMI blood flow grade of 0 or 1 following percutaneous coronary intervention or coronary artery bypass grafting.
• Active infection, meeting at least two of the following criteria: white blood cell count > 12,500/μL, positive blood culture, or fever.
• Thrombus in the right atrium, right ventricle, and/or pulmonary artery.
• History of mechanical valve replacement of the tricuspid or pulmonary valve.
• Severe tricuspid stenosis or regurgitation.
• Severe pulmonary valve stenosis or regurgitation.
• Severe pulmonary hypertension, defined as a pulmonary artery systolic pressure > 60 mmHg.
• Current diagnosis of pulmonary embolism.
• History of pulmonary artery graft replacement (artificial vessel).
• Current use of a right heart assist device or extracorporeal membrane oxygenation (ECMO) device.
• Thrombosis of the internal jugular vein and deep veins of the lower extremities, and/or the presence of a vena cava filter.
• Anatomical conditions that interfere with pump implantation or the safe use of the device, such as aortic dissection, Marfan syndrome, Erdheim-Chirlow disease (i.e., idiopathic medial necrosis, commonly associated with aortic dissection), etc.
• Congenital heart disease that precludes device implantation, or an unrepairated atrial septal defect or patent foramen ovale.
• Allergy or intolerance to contrast agents, or intolerance to anticoagulant or antiplatelet therapy.
• History of thrombolytic therapy within the past 30 days, known coagulation disorders, or hematologic disorders causing blood cell fragility or hemolysis.
• Female patients who are pregnant or breastfeeding.
• Participation in any other clinical trial that may confound the study results or affect the study outcomes.
• Other circumstances deemed by the investigator to be incompatible with inclusion in this study.

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

Оценка устройства

Центры проведения

Китай · 2 центра

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Beijing Anzhen Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07704424 · COREMED_CorVad_RS_FIM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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