Evaluation of the Jarvik 2000 Left Ventricular Assist System With Post-Auricular Connector--Destination Therapy Study
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Non-inferiority to Control Group.
研究概览
简要总结
This investigation will be conducted as an interventional intention-to-treat clinical study in a population of end stage heart failure patients who meet specific inclusion and exclusion criteria. The multi-center study will be prospective, dual-armed, non-blinded (open-label) and randomized, comparing a treatment group receiving the Jarvik 2000 LVAS with Post-Auricular Connector to an active control group treated with the PMA approved Thoratec HeartMate® II LVAS for Destination Therapy.
详细描述
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
- Two year actuarial survival
- Freedom from procedures to repair, or replace the implanted device
- Freedom from stroke resulting in a Modified Rankin Score of >3 at the two-year follow-up
Study Success for Primary Endpoint B will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria B is determined to be superior to that of the Control Group (at three years) according to the pre-specified statistical analysis.
Subject composite success requires the subject to achieve the Effectiveness Endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac transplantation ineligible.
- •Late stage heart failure in NYHA Class IIIb or IV for at least 45 of past 60 days.
- •Cardiac Index < 2.2 L / min / m2
- •LVEF = 25% or less
- •Patients on Optimal Medical Management (OMM) as defined in Section 9.2 OR dependent on intra-aortic balloon counter-pulsation for 7 days OR other temporary (indicated for 30 days use, or less) mechanical circulatory support for 7 days, OR supported with IV inotropes for 7 days and failing to respond.
- •BSA > 1.2 m2 and < 2.5 m2.
排除标准
- •History of cardiac transplantation or left ventricular reduction procedure.
- •Clinical conditions, other than heart failure, which could limit survival to less than three years.
- •Cause of heart failure due to, or associated with, uncorrected thyroid disease, obstructive / restrictive cardiomyopathy, pericardial disease, amyloidosis, dermatomyositis, or active myocarditis.
- •Intolerance to anti-coagulation or anti-aggregation therapy required for post-operative therapy.
- •Known sensitivity to products of bovine origin. The Jarvik 2000 incorporates a Hemashield vascular graft. Patients with a known sensitivity to products of bovine origin should not be implanted.
- •Chronic immunosuppression.
研究组 & 干预措施
Jarvik 2000 Treatment
Jarvik 2000 VAS, Post-Auricular Cable
干预措施: Jarvik 2000 VAS (Device)
HeartMate II Control
HeartMate II VAS Control
干预措施: HeartMate II (Device)
结局指标
主要结局
Non-inferiority to Control Group.
时间窗: 2 years
Study Success for Primary Endpoint A will be established if the proportion of subjects in the Treatment Group meeting the Subject Success Criteria A, is determined to be non-inferior to that of the Control Group (at two years) according to the pre-specified statistical analysis. Subject composite success requires the subject to achieve the Effectiveness Endpoint: 1. Two year actuarial survival 2. Freedom from procedures to repair, or replace the implanted device 3. Freedom from stroke resulting in a Modified Rankin Score of \>3 at the two-year follow-up
次要结局
- Serious adverse events(2 years)
- Quality of life measures: Questionnaire(2 years)