Mechanical Circulatory Support Korea Post Market Surveillance Study (MCS Korea PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Survival rate up to 6 months and 24 months post-implant
研究概览
简要总结
Medtronic is sponsoring this Mechanical Circulatory Support (MCS) Korea Post-Market Surveillance (PMS) to evaluate the safety and performance of the HeartWare Ventricular Assist Device System (HVAD® System) when used in routine clinical care practice in Korea. The MCS Korea PMS is conducted within Medtronic's Product Surveillance Platform (PSR).
详细描述
The MCS Korea PMS is an observational study conducted at two sites. This MCS Korea PMS is required by the Ministry of Food and Drug Safety (MFDS) as a condition of product approval according to Regulation on Medical Device Re-examination. The designated re-examination period is seven years after the approval date (06 Dec 2013 ~ 05 Dec 2020). All patients who require treatment of a commercially available HVAD System for approved indications between the designated re-examination period at a participating PSR site are eligible for enrollment. All enrolled patients will be followed until patient death, transplant, explant (where applicable), or the end of the study, on 05 Dec 2020.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible product
- •Patient is consented within the enrollment window or waiver of consent is approved
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e. no required intervention that could affect interpretation of all-around product safety and or effectiveness)
结局指标
主要结局
Survival rate up to 6 months and 24 months post-implant
时间窗: Implant to 6 months, 24 months
Success (or survival) will be defined as survival, heart transplantation, or explantation for recovery at 6 months post-implant for BTT patients, survival at 24 months post-implant for DT patients.
次要结局
- Quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ), up to 24 months post-implant(Implant up through 24 months)
- Functional status, as measured by the New York Heart Association (NYHA) classification, up to 24 months post-implant(Implant up through 24 months)
- Functional status, as measured by the 6-minute walk test, up to 24 months post-implant(Implant up through 24 months)