Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Hong Kong and Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 3
- 主要终点
- Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
研究概览
简要总结
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure. The PMS will enroll approximately 30 patients, that meet the HM3 commercially approved labelling indications, from approximately 4 sites in Hong Kong and Taiwan. PMS participants will be followed until the 24 months follow-up visit or until they experience an outcome, whichever comes first.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients at the participating sites that are determined to meet the HM3 commercially approved labelling indication and have a planned HM3 implant are eligible to participate in this PMS. Assessment for eligibility criteria is based on medical records of the site and interview with a candidate patient.
排除标准
- 未提供
研究组 & 干预措施
HeartMate 3™ left ventricular assist system (HM3 LVAS)
Patients will be implanted with the HM3 LVAS
干预措施: HeartMate 3™ left ventricular assist system (HM3 LVAS) (Device)
结局指标
主要结局
Primary Efficacy Endpoint: Number of Participants With Overall Survival to Transplant, Myocardial Recovery or on Device Support Free of Debilitating Stroke (Modified Rankin Score >3) or Reoperation for Pump Replacement
时间窗: Up to 6 months follow-up
Overall survival to transplant, myocardial recovery or on device support free of debilitating stroke (Modified Rankin Score \>3) or reoperation for pump replacement will be assessed using the Kaplan-Meier product-limit method along with a competing outcomes graph. Subjects who are urgently transplanted due to a HeartMate 3 malfunction will be considered to have experienced a primary endpoint event, as will subjects who expire, suffer a debilitating stroke or have their HeartMate 3 exchanged due to a device failure. Subjects who are transplanted (except as described above), explanted for recovery, withdraw from the trial or are lost to follow-up will be censored at that time in the analysis.
Primary Safety Endpoint: Number of Cumulative Occurrence of Adverse Events
时间窗: Up to 6 months follow-up
Cumulative occurrence of adverse events will be presented as percent of patients with adverse events
次要结局
- Mean Change in Six-minute Walk Test From Baseline(Baseline and 1 Month post-implant)
- Frequency of Rehospitalization and Reoperation(Up to 6 months follow-up)
- Change Proportion of New York Heart Association (NYHA) Functional Status From Baseline(Baseline and 1 Month post-implant)
- Mean Change in EQ-5D-5L VAS Quality of Life (QoL) From Baseline(Baseline and 1 Month)
- Number of Participants With Device Malfunctions(Up to 6 months follow-up)