Corheart 6 LVAS Long-term Follow-up Study

Официальное название

Long-term Follow-up Study of Corheart 6 Left Ventricular Assist System as Treatment of Patients With Advanced Heart Failure

Обзор

The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure. The study will be a single-arm, prospective, single-center, non-blinded, and non-randomized study with a follow-up duration of five years.

Вмешательства

• Устройство Corheart 6 Left Ventricular Assist System
  Implantation of left ventricular assist device for hemodynamic support

Первичные конечные точки

• Device implantaion success rate at 24 months post-implantation [Срок оценки: Up to 24 months post-implantation]

Вторичные конечные точки (10)

• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire-23 (KCCQ-23) [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation]
• Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) questionnaire [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation]
• Functional status as measured by the Six Minute Walk Test (6MWT) [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation]
• Functional status as measured by the New York Heart Association (NYHA) Classification [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation]
• Stroke severity as assessed with the National Institutes of Health Stroke Scale (NIHSS) score [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation]
• Stroke severity as assessed by the modified Rankin Scale (mRS) score [Срок оценки: Baseline, at 6 months, 12 months, 18 months, and 24 months post-implantation, and as a stoke event occurs, from baseline to 24 months post-implantation]
• Adverse events [Срок оценки: As they occur, from baseline to 24 months post-implantaion]
• Device-related re-operations [Срок оценки: As they occur, from baseline to 24 months post-implantaion]
• Device-related re-hospitalizations [Срок оценки: As they occur, from initial hospital discharge to 24 months post-implantation]
• Overall survival [Срок оценки: Up to 60 months post-implantation]

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years.
• 2\. The patient or legal representative is willing to participate in the study and offers informed consent.
• 3\. Body surface area (BSA) ≥ 1.0 m\^2.
• 4\. Females of childbearing age must agree to use adequate contraception.
• 5\. Patients with NYHA Class IV heart failure symptoms who have failed to be reversed by standardized treatment with oral anti-heart failure drugs.
• 6\. Left Ventricular Ejection Fraction (LVEF) ≤ 35%, and at least one of the following conditions occurs:
• a. Fail to be reversed by or be weaned from intra-aortic balloon pump (IABP), extracorporeal membrane oxygenator (ECMO), or other short-term mechanical circulatory support.
• b. Rely on continuous intravenous administration of one or more vasoactive or inotropic drugs.
• c. Meeting the diagnostic criteria of cardiogenic shock: blood pressure < 90/60mmHg, cardiac index < 2.0 L/min/m\^2 (optional), and pulmonary capillary wedge pressure > 18mmHg (optional).

Критерии исключения

• 1\. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive hypertrophic cardiomyopathy, or pericardial disease.
• 2\. Presence of an active, uncontrolled infection confirmed by a combination of clinical symptoms and laboratory tests.
• 3\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• 4\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/postoperative therapy the investigator will require based on the patient's health status.
• 5\. Patients require bi-ventricular assist device support.
• 6\. Pregnancy.
• 7\. Presence of moderate to severe aortic insufficiency or a history of the mechanical aortic valve that will not be converted to a bioprosthesis or oversewn at the time of implantation.
• 8\. History of any organ transplantation.
• 9\. Presence of uncorrected thrombocytopenia or severe coagulopathy, such as diffuse intravascular coagulation.
• 10\. TBIL (total bilirubin) > 3.0 mg/dL within 48 hours prior to implantation.
• 11\. Serum creatinine (SCr) > 3.0 mg/dL within 48 hours prior to implantation or may require dialysis.
• 12\. Presence of severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease or a diagnosis of primary pulmonary hypertension.
• 13\. Presence of pulmonary embolism within 3 weeks prior to implantation.
• 14\. Pulmonary artery systolic pressure exceeds 60mmHg, combined with at least one of the following 2 parameters demonstrating that pulmonary vascular resistance did not respond to drug therapy:
• a. Pulmonary vascular resistance greater than 8 wood units.
• b. The transpulmonary differential pressure exceeds 20mmHg.
• 15\. Established and untreated abdominal or thoracic aortic aneurysm > 5cm in diameter.
• 16\. Presence of severe peripheral vascular disease with resting pain or extremity ulceration.
• 17\. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management, or brain death from various causes.
• 18\. History of documented disabling stroke within 90 days prior to implantation, a history of cerebrovascular disease, or the presence of uncorrected severe bilateral carotid artery stenosis.
• 19\. History of acute myocardial infarction within 60 days prior to implantation, judged by the investigator to have a risk of myocardial rupture or other surgical high-risk difficult-to-control bleeding, etc.
• 20\. Expected lifetime of less than 1 year due to malignant tumor or other disease.
• 21\. Participation in any other clinical study that may influence the results of this study.
• 22\. Other circumstances that are unforeseen and determined by the researcher to be unsuitable.

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

Китай · 1 центр

• Nanjing First Hospital — Нанкин

Идентификаторы

NCT: NCT06267612 · KY20231109-11

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗