A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 25
- 主要终点
- Overall Survival on Device
研究概览
简要总结
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
详细描述
Patients who participated in prior trials will be approached for this PAS as follows:
- Patients who are on continued HeartWare® System support, (original or exchange device)
- Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •The patient has participated in a prior HeartWare trial under IDE G
- •The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
- •The patient has signed informed consent for participation in the study.
排除标准
- •The patient is unwilling or unable to comply with trial requirements.
- •The patient did not sign the informed consent.
结局指标
主要结局
Overall Survival on Device
时间窗: Implant to 5 years
Overall survival is the probability (expressed as a percent of 100) the participant did not die within 5 years post implant via the Kaplan-Meier method. Participants that did not die were censored at the time of last follow-up or their end of study at 5 years post implant, whichever occurred first.
次要结局
- Change in Functional Status Measured by 6-minute Walk(Change from baseline to 5 years)
- Final Patient Status(Implant to 5 years)
- Number of Participants Experiencing Any Adverse Event Per Intermacs Definition(Enrollment into HW-PAS-03 to 5 years)
- Health Status Change Measured by EuroQol EQ-5D (Version 5L)(Enrollment to 5 years)
- Re-hospitalizations(Enrollment into HW-PAS-03 to 5 years)
- Health Status Change Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)(Change from baseline to 5 years)
- Change in Functional Status Measured by New York Heart Association (NYHA) Class(Change from baseline to 5 years)