Antiplatelet Removal and HemocompatIbility EventS With the HeartMate 3 Pump IDE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 628
- 试验地点
- 51
- 主要终点
- Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
研究概览
简要总结
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo
详细描述
This clinical investigation is a prospective, randomized, double-blinded, placebo-controlled study of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus vitamin K antagonist with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator, site, patient, CEC, and core lab are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject will receive the HeartMate 3 per standard of care (SOC) in accordance with the approved indications for use in the country of implant.
- •Subject will receive the HeartMate 3 as their first durable VAD.
- •Subject must provide written informed consent prior to any clinical investigation related procedure.
- •In female patients of child bearing capability, subject will not be currently pregnant or breastfeeding and on appropriate contraception.
排除标准
- •Post-implant additional temporary or permanent mechanical circulatory support (MCS).
- •Investigator mandated antiplatelet therapy for other conditions (including mandated presence or absence of antiplatelet agent).
- •Patients who are nil per os (NPO) post-implant through day
- •Subjects with a known allergy to acetylsalicylic acid (aspirin).
- •Participation in any other clinical investigation(s) involving an MCS device, or interventional investigation(s) likely to confound study results or affect study outcome.
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
研究组 & 干预措施
Placebo Arm
LVAD Patients on the placebo arm will be given placebo medication
干预措施: LVAD Implant (Device)
Placebo Arm
LVAD Patients on the placebo arm will be given placebo medication
干预措施: Placebo oral tablet (Drug)
Active Arm
LVAD Patients on the active arm will be given 100mg Aspirin
干预措施: LVAD Implant (Device)
Active Arm
LVAD Patients on the active arm will be given 100mg Aspirin
干预措施: Aspirin 100mg (Drug)
结局指标
主要结局
Powered Primary Endpoint of Survival Free of Non-surgical Major Hemocompatibility Related Adverse Events
时间窗: 12 Months
The primary end point was a composite of survival free of non-surgical major hemocompatibility related adverse events (specifically stroke, pump thrombosis, major non-surgical bleeding, and arterial peripheral thromboembolism) at 1-year post implant.
次要结局
- Rates of Non-surgical Major Hemorrhagic Events(Through Study Completion with a Median Follow up of 14 Months)
- Rates of Bleeding Events(Through Study Completion with a Median Follow up of 14 Months)
- Rates of Non-surgical Major Thrombotic Events(Through Study Completion with a Median Follow up of 14 Months)
- Rates of Stroke(Through Study Completion with a Median Follow up of 14 Months)
- Survival Rates(24 Months)
- Risk of Non-Surgical Bleeding Events(24 Months)