Corheart 6 LVAS Clinical Investigation

Официальное название

A Prospective, Multicenter, Single-arm Clinical Investigation of the Corheart 6 Left Ventricular Assist System

Обзор

To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.

Вмешательства

• Устройство Corheart 6 LVAS
  Implantation of left ventricular assist device for mechanical circulatory support

Первичные конечные точки

• Composite Survival Rate without Disabling Stroke [Срок оценки: 6 months after device implantation]

Вторичные конечные точки (10)

• Composite Survival Rate without Disabling Stroke [Срок оценки: 24 months after device implantation]
• Composite Survival Rate [Срок оценки: 5 years after device implantation]
• Bridge Heart Transplantation Rate [Срок оценки: 6 months, 12 months, 24 months, 5 years after surgery]
• Device Removal Rate [Срок оценки: 6 months, 12 months, 24 months, 5 years after surgery]
• NYHA Functional Class assessed using the New York Heart Association (NYHA) Functional Classification (Class I-IV) [Срок оценки: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• KCCQ Questionnaire [Срок оценки: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Anxiety assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7) [Срок оценки: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Depression assessed using the Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: baseline, 6 months, 12 months, 24 months, 5 years after surgery]
• Adverse Events [Срок оценки: 6 months, 12 months, 24 months, 5 years after surgery]
• Device Failure Rate [Срок оценки: 6 months, 12 months, 24 months, 5 years after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years and ≤ 75 years
• The patient has signed an Informed Consent Form
• Body Surface Area (BSA) ≥ 1.2 m2
• New York Heart Association (NYHA) Class IV
• Left Ventricular Ejection Fraction (LVEF) ≤ 25%
• Despite the optimal medical management based on current guidelines, the patient must also meet one or more of the following:
• \- - a. Unable to exercise for HF, or if able to perform cardiopulmonary testing, with peak VO2 <12 mL/kg/min and/or < 50% predicted value;
• \- - b. Progressive end-organ dysfunction (worsening renal and/or hepatic function, type II pulmonary hypertension, cardiac cachexia) due to reduced perfusion and not to inadequately low ventricular filling pressure (PCWP > 20 mmHg and SBP < 90 mmHg or CI < 2.0 L/min/m2).
• \- - c. Impella or IABP assisted; Inotrope dependent/unable to wean from inotropes.

Критерии исключения

• Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
• Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
• Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
• Platelet count < 100,000 x 103/L (< 100,000/ml).
• Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and left ventricular assist system management.
• Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• Presence of an active, uncontrolled infection.
• Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• \- - a. Total bilirubin > 51.3 umol/L (3.0 mg/dl), ischemic hepatitis, or biopsy proven liver cirrhosis, or clinically Child-Pugh B and C score.
• \- - b. History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
• \- - c. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units that is unresponsive to pharmacologic intervention.
• \- - d. History of stroke within 180 days prior to enrollment, or a history of cerebrovascular disease with symptomatic (> 70%) carotid artery stenosis
• \- - e. Serum creatinine ≥ 265umol/L (3.0mg/dl) or requiring dialysis.
• \- - f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
• Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
• History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• Uncontrollable ventricular tachyarrythmias / ventricular fibrillation (VF).
• STEMI <2 weeks before planned implantation.
• Right ventricular failure as defined by one or more of the following:
• \- - a. Severe depressed RV function in echocardiography
• \- - b. TAPSE < 1.0 cm
• \- - c. CVP/PCWP ratio > 0.63
• Planned Bi-VAD support prior to enrollment.
• Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
• History of any organ transplant.
• Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
• Any condition other than HF that could limit survival to less than 24 months
• Positive pregnancy test if of childbearing potential.
• Lactating mothers.
• Participation in any other clinical investigation that is likely to confound study results or affect the study.
• Patients who have been placed in an institution by court order or by order of the authorities.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07700810 · COREMED_Corheart 6

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗