A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 51
- 主要终点
- Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
研究概览
简要总结
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database.
All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
- •Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
- •Subject signed an Intermacs® informed consent if required by local IRB policy.
- •Subject signed a HeartWare informed consent.
排除标准
- •Subject is incarcerated (prisoner).
- •Subject did not sign the informed consent at sites where waiver of consent was not granted.
- •Body Surface Area (BSA) < 1.2 m^
- •Prior cardiac transplant or cardiomyoplasty.
- •Subject is receiving a BiVAD.
- •Subject is receiving the device as an RVAD.
- •Subject data is generated from non- Intermacs® centers.
- •Pediatric subjects (< 19 years of age).
- •Subjects who receive a temporary LVAD
- •Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
- •Severe Right Heart failure
- •Aortic insufficiency or mechanical aortic valve.
- •Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
- •Known LV Thrombus.
结局指标
主要结局
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months
时间窗: 6 months
* Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or * Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event).
次要结局
- Mean Length of Initial Hospital Stay(Initial Hospital Stay)