NCT06174103招募中不适用
BiVACOR® Total Artificial Heart Early Feasibility Study
BiVACOR Inc.8 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年6月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 8
- 主要终点
- Feasibility Endpoint
研究概览
简要总结
The purpose of this study is to assess the feasibility of using the BiVACOR Total Artificial Heart (TAH) System to support adult patients with severe biventricular heart failure, or univentricular heart failure in which left ventricular assist device (LVAD) support is not recommended, who require mechanical circulatory support to sustain life. The BiVACOR TAH System is intended for use as a bridge to transplant (BTT). Feasibility will be assessed by evaluating safety and performance of the BiVACOR TAH System in study subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has severe, irreversible biventricular heart failure and is eligible for biventricular mechanical circulatory support based on the International Society of Heart and Lung Transplantation (ISHLT) guidelines or has univentricular heart failure in which LVAD support is not recommended. ISHLT Guidelines for Biventricular Support:
- •Biventricular failure with 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 g/m/beat/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) > 15mmHg
- •CVP to pulmonary capillary wedge pressure (PCWP) ratio > 0.63
- •Tricuspid insufficiency grade 4
- •Pulmonary artery pressure index (PAPi) < 2
- •Treatment-refractory recurrent and sustained ventricular tachycardia or ventricular fibrillation in the presence of untreatable arrhythmogenic pathologic substrate.
- •Heart failure due to restrictive or constrictive physiology (e.g., hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative heart disease).
- •Patient is categorized as INTERMACS Patient Profile Classification 2 or
- •Patient is classified as NYHA Class IV.
- •Patient has a left ventricular ejection fraction (LVEF) ≤ 25%, with the exception of patients with restrictive or constrictive physiology.
- •Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 L/min/m2 without inotropes if inotropes are contraindicated (e.g., restrictive or constrictive heart failure), and meets one of the following criteria:
- •Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
- •Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or similar temporary mechanical circulatory support device (MCSD) for at least seven days.
- •Patient is eligible for cardiac transplantation as determined by the implanting center.
- •Patient has adequate room in the chest as determined by 3-D imaging or other standard clinical assessments.
- •Patient has read and understands the informed consent form (ICF) and has voluntarily provided informed consent.
排除标准
- •Patient has contraindications to anticoagulation or antiplatelet therapies.
- •Patient has coagulopathy defined by a platelet count < 50 k/µl.
- •Patient has insufficient space in the chest to accommodate the BiVACOR pump.
- •Patient has a body mass index (BMI) ≥ 35 kg/m
- •Patient is highly pre-sensitized prior to pump implantation.
- •Patient is unconscious and unresponsive.
- •Patient is on pre-implant extracorporeal membrane oxygenation (ECMO) for > 7 days.
- •Patient is on pre-implant temporary MCSD for more than 21 days [e.g., Intra-aortic balloon pump (IABP), Impella, CentriMag, etc.] unless ambulatory and free from adverse effects associated with the MCSD.
- •Patient is implanted with durable mechanical circulatory support (LVAD or RVAD).
- •Patient experienced cerebrovascular accident (CVA) within three months of eligibility evaluation.
- •Patient has severe end-organ dysfunction as evidenced by:
- •Total bilirubin > 4.0 mg/dL or cirrhosis confirmed by imaging or positive biopsy, and/or
- •Glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or renal replacement therapy dependence.
- •Patient has severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen.
- •Patient has primary pulmonary hypertension ≥ 8 Wood units.
- •Patient has severe systemic light-chain amyloidosis.
- •Patient has been diagnosed with severe cardiac cachexia or irreversible frailty.
- •Patient has diabetes with advanced diabetic neuropathy with accompanying skin ulceration.
- •Patient has a blood-borne infection within seven days of eligibility evaluation. Positive blood cultures reflective of contaminants (e.g., Staphylococcus epidermidis) will not be considered an exclusion.
- •Patient is pregnant or planning pregnancy.
- •Patient has a co-morbidity or illness that would limit survival to less than two years.
- •Patient has a current drug and/or alcohol addiction or known substance abuse.
- •Patient has insufficient social support or a history of non-compliance with medical instructions as determined by the Investigator.
- •Patient is participating in another clinical trial that may impact or confound the results of the BiVACOR TAH EFS.
结局指标
主要结局
Feasibility Endpoint
时间窗: 6 months or time of heart transplant (if prior to 6 months post pump implant)
Survival on the original BiVACOR pump
Safety Endpoint
时间窗: Through 6 months
Evaluation of the safety of the BiVACOR TAH System using INTERMACS adverse event (AE) terms and definitions (INTERMACS Manual of Operations Version 5).
次要结局
未报告次要终点
研究者
研究点 (8)
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