NCT05474092招募中不适用
Evaluation of the Aeson® Total Artificial Heart (TAH) System in a Post-Market Approval Setting
Carmat SAS1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2021年11月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness of the Aeson TAH system when used in routine care by surgeons.
详细描述
The Primary objective/endpoint is survival rate on the originally implanted Aeson device at 90 days post-implant (H1 > 64%).
The second objectives/endpoints are:
- Confirm the performance and safety profile of the device for patients implanted with the Aeson TAH system until being transplanted:
- Survival at 6, 12, 18, and 24-months post-implant, and total support duration before transplantation;
- Health status change as measured by NYHA classification, 6MWT and Quality of Life Questionnaire (EQ-5D-5L);
- Renal and hepatic function as measured by biological parameters;
- Hemocompatibility profile measured by biological parameters and incidence of hemocompatible-related adverse events;
- Frequency and Incidence of Serious Adverse events.
- Assess the effectiveness of device upgrades
- Confirm the safety profile of the device for patients after being transplanted.
- Survival at 30 days, 6 months, and 12 months post-transplant
- Frequency and Incidence of Serious Adverse Event of special interest as graft reject, neurological events, major bleeding.
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 is intended to receive an Aeson TAH system according to the IFU indications within standard medical practice
- •Patient has provided written informed consent using the Ethics Committee approved consent form
- •Non-inclusion Criteria:
- •Vulnerable populations who could not voluntarily consent to participate in the study
排除标准
- 未提供
结局指标
主要结局
Survival rate
时间窗: 90 days post-implant
Proportion of patients surviving on the originally implanted Aeson device (superiority test \> 64%)
次要结局
- Frequency and Incidence of Serious Adverse events before transplantation(3, 6, 9, 12, 18 and 24-months post-implant)
- Functional status change before transplantation(3, 6, 9, 12, 18 and 24-months post-implant)
- Length of hospital stay and time at home before transplantation(3, 6, 9, 12, 18 and 24-months post-implant)
- Survival and total support duration before transplantation(6, 12, 18 and 24-months post-implant)
- Health status change before transplantation(3, 6, 9, 12, 18 and 24-months post-implant)
- Assess the effectiveness of device upgrades(Between 3 and 24 months post-implantation, when heart transplant occurred)
- Confirm the safety profile of the device after transplantation(30 days, 3 months, 6 months, 12 months post-transplantation)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
SynCardia 70cc TAH-t for Destination Therapy (DT)Life-threateningBiventricular Heart FailureIneligible for Cardiac TransplantNCT02232659SynCardia Systems. LLC38
终止
不适用
Syncardia 50cc TAH-t as a Bridge to TransplantHeart Failure, Right-SidedCardiac FailureHeart Failure, Left-SidedNCT02459054SynCardia Systems. LLC16
已完成
不适用
ACT DiamondTemp TempeRAture-Controlled and Contact Sensing RF Ablation Clinical Trial for Atrial FibrillationParoxysmal Atrial FibrillationNCT02821351Medtronic Cardiac Ablation Solutions70
已完成
不适用
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High RiskSymptomatic Severe Aortic StenosisNCT01314313Edwards Lifesciences2,032
Unknown
不适用
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic InsufficiencyAortic InsufficiencyNCT05424653Chengdu Silara Meditech Inc.10