Corheart 6 LVAS Study

Официальное название

Prospective Multi-Center Single-Arm Study for Evaluating the Corheart 6 Left Ventricular Assist System

Обзор

The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation. The secondary objective is to assess the long-term safety and effectiveness of Corheart 6 LVAS treatment.

Вмешательства

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

Первичные конечные точки

• Composite of surivival [Срок оценки: Up to 6 months post-implantation]

Вторичные конечные точки (7)

• Survival [Срок оценки: Year 1, Year 2, Year 3, Year 4, Year 5]
• Composite of surivival [Срок оценки: Year 1, Year 2, Year 5]
• Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [Срок оценки: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Quality of Life as measured by the EuroQoL-5D-5L (EQ-5D-5L) [Срок оценки: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Functional status as measured by the Six Minute Walk Test (6MWT) [Срок оценки: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Functional status as measured by the New York Heart Association (NYHA) Classification [Срок оценки: Baseline, Month 3, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Adverse Events [Срок оценки: As they occurred, from Baseline to Year 5]

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years and ≤ 75 years
• 2\. The patient has signed an Informed Consent Form
• 3\. Body Surface Area (BSA) ≥ 1.2 m\^2
• 4\. New York Heart Association (NYHA) Class IV
• 5\. Left Ventricular Ejection Fraction (LVEF) ≤ 25%
• 6\. 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;
• d. Inotrope dependent/unable to wean from inotropes.

Критерии исключения

• 1\. Heart failure who can be treated with other therapy options (e.g. CRT, CRT-D, etc.)
• 2\. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients' health status.
• 3\. Patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia type II.
• 4\. Platelet count < 100,000 x 10\^3/L (< 100,000/ml).
• 5\. Psychiatric disease/ disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and ventricular assist system management.
• 6\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• 7\. Presence of an active, uncontrolled infection.
• 8\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• a. Total bilirubin > 51.3 μmol/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 ≥ 265 μmol/L (3.0mg/dl) or requiring dialysis.
• f. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• 9\. Etiology of heart failure (HF) due to or associated with uncorrected thyroid disease, obstructive/ restrictive cardiomyopathy, pericardial disease, amyloidosis or giant cell myocarditis.
• 10\. Uncorrected moderate to severe aortic insufficiency without plans for correction during pump implant.
• 11\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• 12\. Uncontrollable ventricular tachyarrythmias/ ventricular fibrillation (VF).
• 13\. STEMI <2 weeks before planned implantation.
• 14\. 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
• 15\. Planned Bi-VAD support prior to enrollment.
• 16\. Cardiac arrest with a history of resuscitation 1-month before inclusion, without full restoration of cognitive function.
• 17\. History of any organ transplant.
• 18\. Pre albumin < 150 mg/L, or Albumin < 30g/L (3 g/dL).
• 19\. Any condition other than HF that could limit survival to less than 24 months.
• 20\. Positive pregnancy test if of childbearing potential.
• 21\. Lactating mothers.
• 22\. Participation in any other clinical investigation that is likely to confound study results or affect the study.
• 23\. 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

Германия · 7 центров

• Herz-und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen
• Deutsches Herzzentrum der Charité — Berlin
• Klinikum Links der Weser — Bremen
• Universitätsklinikum Hamburg — Hamburg
• Universitätsklinikums Heidelberg — Heidelberg
• Herzzentrum Leipzig — Leipzig
• Universitätsklinikum Würzburg — Würzburg

Австрия · 2 центра

• Universitätsklinikum Graz — Graz
• Universitätskliniken der MedUni Wien — Vienna

Италия · 2 центра

• IRCCS Ospedale San Raffaele — Milan
• Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Torino

Идентификаторы

NCT: NCT05876000 · COREMED_EU_LVAS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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