DuoCor 2 DOMINATE Study

Официальное название

A Prospective, Multi-Center, Single-Arm Study for the Evaluation of the DuOCor 2 Ventricular Assist SysteM In Patients With AdvaNced BIventriCulAr HearT FailurE

Обзор

Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation. In such cases, medical treatments often prove ineffective, necessitating advanced treatment. Heart transplantation is the standard treatment for these patients, but it is severely limited by the shortage of donor hearts. As a result, mechanical circulatory support (MCS) devices are often employed. However, the most common form, the left ventricular assist device (LVAD), is only suitable for patients with isolated left ventricular dysfunction. This leaves a significant treatment gap for patients with biventricular failure. For this population, current options, such as total artificial hearts (TAHs) and biventricular assist devices (BiVADs), are associated with significant challenges, including high rates of adverse events and suboptimal long-term outcomes. The DuoCor Ventricular Assist System (VAS) is a next-generation MCS device specifically developed to address this need by providing simultaneous biventricular support. It incorporates two compact, good hemocompatible blood pumps designed for implantation in both the left and right heart, controlled via a single driveline and external controller. It aims to reduce surgical complexity, improve patient mobility, and minimize complications such as thrombosis and infection. The primary objective of this study is to evaluate the safety and efficacy of the DuoCor VAS as a treatment for advanced biventricular heart failure.

Вмешательства

• Устройство DuoCor Ventricular Assist System
  Implantation of the DuoCor Ventricular Assist System for mechanical circulatory support.

Первичные конечные точки

• Composite of survival at 6 months post-implantation [Срок оценки: 6 months]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 1\. Age ≥ 18 years and ≤ 75 years
• 2\. Patient is inotrope dependent, OR has a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes
• 3\. Patient has left heart failure with at least one of the following criteria:
• Left ventricular ejection fiction (LVEF) ≤ 30%;
• Pulmonary capillary wedge pressure (PCWP) > 15mmHg.
• 4\. Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the ISHLT guideline. This includes at least two of the following hemodynamic and/or echocardiographic measurements:
• Right ventricular ejection fraction (RVEF)≤ 30%;
• Right ventricular stroke work index (RVSWI)≤ 0.25 mmHg\*L/m2;
• Tricuspid annular plane systolic excursion (TAPSE)≤ 14 mm;
• Right ventricular (RV) to left ventricular (LV) end-diastolic diameter ratio> 0.72;
• Central venous pressure (CVP)> 15 mmHg;
• CVP to PCWP ratio> 0.63;
• Tricuspid insufficiency grade 2-4;
• Pulmonary artery pressure index (PAPi)< 2;
• 5\. Patient or its legal representative has signed the informed consent, has full understanding of procedures and the study, and is committed to following study requirements.

Критерии исключения

• 1\. Known intolerance to anticoagulant or antiplatelet therapies.
• 2\. Etiology of heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis /senile or other infiltrative heart disease).
• 3\. Coagulopathy defined by platelets < 100k/µl or INR ≥ 1.5 not due to anticoagulant therapy.
• 4\. Technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator.
• 5\. Presence of temporary mechanical circulatory support such as Impella (all types) or IABP with a duration greater than 21 days.
• 6\. Presence of ECMO with a duration greater than 10 days.
• 7\. Patient is implanted with durable mechanical circulatory support (LVAD or RVAD) and has refused to switch to the study device.
• 8\. Patient experienced cerebrovascular accident (CVA) within 3 months of eligibility evaluation.
• 9\. Presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
• Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy;
• Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacement therapy dependence;
• History of severe chronic obstructive pulmonary disease (COPD) defined by FEV1/FVC < 0.7, or FEV1 < 50% predicted.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration;
• 10\. Fixed pulmonary hypertension with a most recent PVR ≥ 8 Wood units.
• 11\. Severe systemic light-chain amyloidosis.
• 12\. Blood stream infection within seven days. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
• 13\. Sepsis
• 14\. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
• 15\. Any condition other than HF that could limit survival to less than 24 months.
• 16\. Positive pregnancy test if of childbearing potential.
• 17\. Lactating mothers.
• 18\. Participation in any other clinical investigation that is likely to confound study results or affect the 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

Лечение

Центры проведения

Германия · 1 центр

• Medizinische Hochschule Hannover — Hanover

Идентификаторы

NCT: NCT07233876 · COREMED_EU_DuoCor

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗